FDA 510(k) Applications for Medical Device Product Code "GDW"
(Staple, Implantable)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K001807 | ADVANCED UROSCIENCE, INC. | TISSUE MARKER | 05/03/2001 |
| K222487 | Anika Therapeutics, Inc. | Anika Tissue Tack Fixation System | 05/08/2023 |
| K190331 | Applied Medical Resources Corporation | Applied Medical Laparoscopic Linear Cutter | 11/22/2019 |
| K152618 | B. J. ZH. F. PANTHER MEDICAL EQUIPMENT CO.,LTD | PANTHER Cutter Stapler | 11/12/2015 |
| K142577 | B.J.Z.H.F. Panther Medical Equipment Co. Ltd. | PANTHER Endo Linear Cutter Staplers with Single Use Loading Units | 06/11/2015 |
| K103470 | B.J.ZH.F. PANTHER MEDICAL EQUIPMENT CO., LTD | PANTHER GROUP OF SURGICAL INCLUDES: OANTHER CIRCULAR STAPLER; PANTHER HEMORRHOIDAL CIRCULAR STAPLER; PANTHER LINEAR STAP | 01/11/2011 |
| K201639 | Beijing Biosis Healing Biological Technology Co., Ltd. | Disposable Circular Staple, Disposable Hemorrhoidal Stapler, Disposable Linear Stapler and Reloads, Disposable Linear Cutter Stapler and Reloads, Disposable Endoscopic Linear Cutter Stapler and Reloads | 05/27/2021 |
| K041331 | BIOPSY SCIENCES, LLC | BIOPSY SCIENCES, LLC, LUNG BIOPSY SITE MARKER | 06/15/2004 |
| K970817 | BIOPSYS MEDICAL, INC. | MICROMARK CLIP | 09/11/1997 |
| K963015 | BIOPSYS MEDICAL, INC. | SURGICAL STAPLE MARKER DEVICE (MODIFY) | 10/07/1996 |
| K123718 | C.R. BARD INC | PERMASORB DISPOSABLE FIXATION DEVICE | 01/22/2013 |
| K163698 | C.R. BARD INC, | OptiFix Open Absorbable Fixation System - 20 absorbable fasteners | 04/11/2017 |
| K160900 | C.R. BARD INC. | CapSure Fixation System - Straight 5mm x 37 cm û 30 Permanent fasteners, CapSure Fixation System - Straight 5mm x 37 cm û 15 Permanent fasteners | 05/31/2016 |
| K170278 | C.R. BARD INC. | OptiFix AT Absorbable Fixation System with Articulating Technology - 30 Fasteners, OptiFix AT Absorbable Fixation System with Articulating Technology - 15 Fasteners | 05/31/2017 |
| K092483 | C.R. BARD, INC. | BARD PERMAFIX FIXATION SYSTEM, MODEL 0113012, 0113014, 0113016, 0116018 | 12/18/2009 |
| K082396 | C.R. BARD, INC. | DAVOL ABSORBABLE FASTENER SYSTEM, MODEL (S) 0113080,0113081, 0113082, 0113084, 0113086, 0113087 | 01/02/2009 |
| K132134 | C.R. BARD, INC. | OPTIFIX ABSORBABLE FIXATION SYSTEM | 12/02/2013 |
| K111153 | C.R. BARD, INC. | SORBAFIX (TM) ABSORBABLE FIXATION SYSTEM, PERMAFIX (TM) FIXATION SYSTEM | 05/24/2011 |
| K142873 | C.R.Bard Inc. | OptiFix Fixation System - Straight 5mm X 39 cm - 30 absorbable fasteners, OptiFix Fixation System - Straight 5mm x 39 cm - 15 absorbable fasteners | 03/12/2015 |
| K032347 | CARBON MEDICAL TECHNOLOGIES, INC. | BIOMARC TISSUE MARKER | 08/21/2003 |
| K161137 | CARDICA, INC. | Dextera MicroCutter 5/80 Blue Reload, Dextera MicroCutter 5/80 Blue Curved Tip Reload | 07/20/2016 |
| K140118 | CARDICA, INC. | MICROCUTTER XCHANGE 30 STAPLER, MICROCUTTER XCHANGE 30 BLUE CARTRIDGE | 02/25/2014 |
| K151081 | Cardica, Inc. | MicroCutter XCHANGE 30 Stapler, MicroCutter XCHANGE 30 Blue Cartridge, MicroCutter XCHANGE 30 White Cartridge | 01/15/2016 |
| K140170 | CARDICA, INC. | MICROCUTTER XCHANGE 30 STAPLER, MICROCUTTER XCHANGE 30 WHITE CARTRIDGE | 02/19/2014 |
| K132581 | CARDICA, INC. | MICROCUTTER XCHANGE 30, MICROCUTTER XCHANGE 30, BLUE STAPLE CARTRIDGE, BLUE STAPLE CARTRIDGE | 01/07/2014 |
| K131303 | CHANGZHOU CITY ZHIYE MEDICAL DEVICES INSTITUTE CO. | DISPOSABLE CIRCULAR STAPLER | 06/11/2013 |
| K172561 | Changzhou Kangdi Medical Stapler Co., Ltd. | Disposable Circular Stapler | 12/05/2017 |
| K100723 | CHANGZHOU KANGDI MEDICAL STAPLER CO., LTD. | DISPOSABLE CIRCULAR STAPLER, DISPOSABLE CIRCULAR STAPLER MODEL KYGW-25.5, KYGW-28.5 | 04/30/2010 |
| K121474 | CHANGZHOU KANGDI MEDICAL STAPLER CO., LTD. | DISPOSABLE LINEAR STAPLER, DISPOSABLE LINEAR CUTTER | 07/16/2012 |
| K172538 | Changzhou Kangdi Medical Stapler Co.,Ltd. | Disposable Linear Stapler, Disposable Linear Cutter | 11/30/2017 |
| K131511 | CHANGZHOU SINOLINKS MEDICAL INNOVATION CO., LTD | DISPOSABLE CIRCULAR STAPLER, DISPOSABLE CURVED CUTTER STAPLER, DISPOSABLE LINEAR STAPLERS AND RELOADS, DISPOSABLE HEMORR | 07/05/2013 |
| K100386 | CHANGZHOU WASTON MEDICAL APPLIANCE CO. LTD | DISPOSABLE CIRCULAR STAPLER, MODELS WHY-25, WHY-29. WHY 32 | 03/01/2010 |
| K211197 | Changzhou Waston Medical Appliance Co., Ltd | Disposable Endoscopic Cutter Stapler and Cartridge | 01/19/2023 |
| K161905 | CHANGZHOU XIN NENG YUAN MEDICAL STAPLER CO.,LTD. | Disposable Circular Stapler for Hemorrhoids, Disposable Circular Stapler, Disposable Linear Stapler, Disposable Endoscopic Linear Cutter Stapler and Cartridge, Disposable Linear Cutter Stapler and Stapler Cartridge | 11/17/2016 |
| K162947 | CHONGQING QMI SURGICAL CO., LTD | Disposable End-to-end Anastomosis Circular Stapler; Universal Endoscopic Linear Cutting Stapler and Single Use Loading Unit; Linear Cutting Stapler and Single Use Loading Unit; Disposal Hemorrhoidal Circular Stapler | 03/03/2017 |
| K123109 | COVIDIEN | ABSORBATACK 5MM SINGLE USE ABSORBABLE FIXATION DEVICE | 10/23/2012 |
| K221003 | Covidien | Autosuture EEA Stapler / circular stapler with DST Series Technology / EEA Autosuture Circular Stapler with DST Series Technology / DST Series EEA Stapler / DST EEA | 09/30/2022 |
| K102291 | COVIDIEN | COVIDIEN ENDO GIA RADIAL RELOAD WITH TRI-STAPLE TECHNOLOGY | 09/15/2010 |
| K172361 | Covidien | EEA Circular Stapler with Tri-Staple Technology | 02/16/2018 |
| K202507 | Covidien | EEA Circular Stapler with Tri-Staple Technology | 01/21/2021 |
| K221771 | Covidien | EEA Circular Stapler with Tri-Staple Technology | 11/30/2022 |
| K192330 | Covidien | EEA Circular Stapler with Tri-Staple Technology | 01/23/2020 |
| K221005 | Covidien | EEA Circular Stapler with Tri-Staple Technology | 04/29/2022 |
| K133938 | COVIDIEN | ENDO GIA REINFORCED RELOAD WITH TRI-STAPLE TECHNOLOGY | 01/22/2014 |
| K221013 | Covidien | GIA Auto Suture Stapler with DST Series Technology | 05/05/2022 |
| K221006 | Covidien | GIA Stapler with Tri-Staple Technology | 04/29/2022 |
| K202701 | Covidien | GIA Stapler with Tri-Staple Technology | 12/07/2020 |
| K192720 | Covidien | GIA Stapler with Tri-Staple Technology | 03/13/2020 |
| K231240 | Covidien | MaxTackÖ Motorized Fixation Device | 09/08/2023 |
| K140609 | COVIDIEN | RELIATACK ARTICULATING RELOADABLE FIXATION DEVICE WITH STANDARD PURCHASE ABSORBLE TACKS | 04/09/2014 |
| K182475 | Covidien | Signia Circular Adapters (for use with Signia Staplers), Tri-Staple 2.0 Circular Reloads (for use with Signia Circular Adapters) | 03/14/2019 |
| K170348 | Covidien | Signia Four-Bay Smart Charger (to be used with Signia Stapler) | 03/02/2017 |
| K191070 | Covidien | Signia Small Diameter Reloads | 09/04/2019 |
| K160176 | Covidien | Signia Stapler | 04/26/2016 |
| K201672 | Covidien | Signia Stapler (with new software) | 07/17/2020 |
| K222641 | Covidien | SigniaÖ Small Diameter Reloads Including Regular (Round) Tip Version | 11/29/2022 |
| K173270 | Covidien | Tri-Staple 2.0 Reinforced Reload | 02/20/2018 |
| K202864 | Covidien | Tri-Staple 2.0 Reloads | 10/28/2020 |
| K132493 | Covidien LLC | ENDO GIA RADIAL RELOAD WITH TRI-STAPLE TECHNOLOGY | 10/23/2013 |
| K133762 | Covidien LLC | ENDO GIA(TM) EXTRA LONG ADAPTER | 01/08/2014 |
| K151659 | Covidien LLC | ReliaTack Articulating Reloadable Fixation Device with Deep Purchase Reloadable Tacks | 07/17/2015 |
| K151163 | Covidien LLC | Signia Loading Unit, Tri-Staple 2.0 Cartridge | 05/29/2015 |
| K163098 | Covidien LLC | Tri-Staple 2.0 Intelligent Cartridge | 12/05/2016 |
| K102325 | COVIDIEN LLC, FORMERLY REGISTERED AS TYCO HEALTHCA | IDRIVE SYSTEM (I DRIVE POWER HANDLE, IDRIVE (RALC) SINGLE USE RELOAD) | 10/13/2010 |
| K091900 | COVIDIEN LP, FORMERLY REGISTERED AS UNITED STATES | ABSORBATACK 5MM SINGLE USE ABSORBABLE FIXATION DEVICE | 07/16/2009 |
| K083519 | COVIDIEN LP, FORMERLY REGISTERED AS UNITED STATES | AUTOSUTURE ENDO GIA STAPLERS WITH ENDO GIA SINGLE USE LOADING UNITS | 04/10/2009 |
| K120258 | COVIDIEN, FORMERLY US SURGICAL A DIVISON OF TYCO H | DUET TRS RELOADS, DUET TRS RELOADS WITH TRI-STAPLE TECHNOLOGY, ENDO GIA UNIVERSAL AND ULTRA UNIVERSAL STAPLERS | 02/29/2012 |
| K131705 | COVIDIEN, FORMERLY US SURGICAL A DIVISON OF TYCO H | ENDO GIA RADIAL RELOAD WITH TRI-STAPLE TECHNOLOGY | 07/01/2013 |
| K130717 | COVIDIEN, FORMERLY US SURGICAL A DIVISON OF TYCO H | ENDO GIA RELOAD | 04/18/2013 |
| K103263 | COVIDIEN, FORMERLY US SURGICAL A DIVISON OF TYCO H | ENDO GIA SINGLEUSE DUET TRS RELOAD WITH TRI0STAPLE TECHNOLOGY | 11/22/2010 |
| K111825 | COVIDIEN, FORMERLY US SURGICAL A DIVISON OF TYCO H | ENDO GIA(TM) STAPLERS, DST SERIES(TM) GIA(TM) STAPLERS, DST SERIES(TM) TA(TM) STAPLERS | 10/25/2011 |
| K123318 | COVIDIEN, FORMERLY US SURGICAL A DIVISON OF TYCO H | IDRIVE ULTRA POWERED HANDLE AND ENDO GIA ADAPTER | 12/18/2012 |
| K121510 | COVIDIEN, FORMERLY US SURGICAL A DIVISON OF TYCO H | IDRIVE ULTRA POWERED HANDLE ENDO GIA ADAPTER | 07/25/2012 |
| K122781 | COVIDIEN, FORMERLY US SURGICAL A DIVISON OF TYCO H | RELIAMAX GASTROINTESTINAL ANASTOMOSIS AND RELOAD | 02/05/2013 |
| K142808 | CR BARD INC | CapSure Fixation System-Straight 5mm x 37 cm-30 Permanent fasteners, CapSure Fixation System-Straight 5mm x 37 cm-15 Permanent fasteners | 03/09/2015 |
| K190884 | Datascope Corp. | TigerPaw Pro Left Atrial Appendage Occlusion Fastener And Delivery Tool | 12/26/2019 |
| K050610 | DAVOL INC., SUB. C.R. BARD, INC. | SALUTE FIXATION SYSTEM | 05/25/2005 |
| K051848 | DAVOL INC., SUB. C.R. BARD, INC. | SALUTE II DISPOSABLE FIXATION DEVICE, MODELS 0113070, 0113072, 0113073, 0113077, 0113079 | 08/11/2005 |
| K191287 | Davol Inc., Subsidiary of C.R. Bard | OptiFix AT Absorbable Fixation System with Articulating Technology û 30 Fasteners, OptiFix AT Absorbable Fixation System with Articulating Technology û 15 Fasteners | 07/16/2019 |
| K171561 | Dextera Surgical Inc. | Dextera MicroCutter 30 Blue Reload, Dextera MicroCutter 30 Curved Tip Blue Reload, Dextera MicroCutter 30 White Reload, Dextera MicroCutter 30 Curved Tip White Reload | 08/28/2017 |
| K110728 | EASYLAP LTD. | IMESH TACKER | 06/08/2011 |
| K150026 | ETHICON ENDO-SURGERY, LLC | Endopath ETS-Flex45 Endoscopic Articulating Linear Cutter, Endopath ETS-Flex45 No-Knife Articulating Linear Stapler | 05/18/2015 |
| K080972 | ETHICON ENDO-SUGERY, LLC | ECHELON ZEBRA CARTRIDGES, MODELS, Z45WB, Z45BG, Z45GP, Z60WB, Z60BG, ZP60GP | 07/03/2008 |
| K223760 | Ethicon Endo-Surgery | ECHELON LINEARÖ 60 mm Cutter (GLC60);ECHELON LINEARÖ 80mm Cutter (GLC80);ECHELON LINEARÖ 100 mm Cutter (GLC100);ECHELON LINEARÖ Cutters 60mm Blue Reload (GLCR60B);ECHELON LINEARÖ Cutters 60mm Green Reload (GLCR60G);ECHELON LINEARÖ Cutters 80mm Blue Reloa | 03/15/2023 |
| K201280 | Ethicon Endo-Surgery LLC | Ethicon Circular Stapler, Ethicon Circular Stapler -XL Sealed | 07/27/2020 |
| K091322 | ETHICON ENDO-SURGERY, INC. | CONTOUR CURVED CUTTER STAPLER AND RELOADS, MODELS: CS40B, CS40G, CR40B, CR40G | 06/01/2009 |
| K053631 | ETHICON ENDO-SURGERY, INC. | CONTOUR TRANSTAR CURVED CUTTER STAPLER SET | 01/30/2006 |
| K040038 | ETHICON ENDO-SURGERY, INC. | CURVED CUTTER STAPLER, MODELS CS40B, CS40G; RELOAD FOR CURVED STAPLER, MODELS CR40B, CR40G | 02/04/2004 |
| K110385 | ETHICON ENDO-SURGERY, INC. | ECHELON FLEX 45 / 60 POWERED ARTICULATING ENDOSCOPIC LINEAR CUTTER | 03/25/2011 |
| K141952 | ETHICON ENDO-SURGERY, INC. | ECHELON FLEX POWERED VASCULAR STAPLER WITH ADVANCED PLACEMENT TIP, ENDOPATH ECHELON VASCULAR WHITE RELOADS FOR ADVANCED | 11/24/2014 |
| K013749 | ETHICON ENDO-SURGERY, INC. | ENDOANCHOR AND OPENANCHOR | 02/11/2002 |
| K051002 | ETHICON ENDO-SURGERY, INC. | ENDOPATH ENDOCUTTER 60 ENDOSCOPIC LINEAR CUTTER | 05/17/2005 |
| K061156 | ETHICON ENDO-SURGERY, INC. | ENDOPATH ENDOCUTTER 60 ENDOSCOPIC LINEAR CUTTER, MODELS EC60, SC60 AND LONG60 AND ENDOPATH & PROXIMATE LINEAR CUTTERS | 07/03/2006 |
| K102632 | ETHICON ENDO-SURGERY, INC. | ETHICON ENDO-SURGERY 5MM LAPAROSCOPIC MULTI-FEED STAPLER | 10/07/2010 |
| K020779 | ETHICON ENDO-SURGERY, INC. | PROXIMATE AND ENDOPATH LINEAR CUTTERS AND STAPLERS | 06/05/2002 |
| K983536 | ETHICON ENDO-SURGERY, INC. | PROXIMATE CURVED AND STRAIGHT INTRALUMINAL STAPLERS | 12/18/1998 |
| K991030 | ETHICON ENDO-SURGERY, INC. | PROXIMATE HCS HEMORRHOIDAL CIRCULAR STAPLER AND ACCESSORIES | 05/17/1999 |
| K030925 | ETHICON ENDO-SURGERY, INC. | PROXIMATE HCS HEMORRHOIDAL CIRCULAR STAPLER AND ACCESSORIES, MODEL PPH01 | 05/15/2003 |
| K051301 | ETHICON ENDO-SURGERY, INC. | PROXIMATE PPH HEMORRHOIDAL CIRCULAR STAPLER AND ACCESSORIES | 08/30/2005 |
| K030411 | ETHICON ENDO-SURGERY, INC. | PROXIMATE PPH HEMORRHOIDAL CIRCULAR STAPLER AND ACCESSORIES, MODEL PPH03 | 03/20/2003 |
| K111195 | ETHICON ENDO-SURGERY, INC. | VALUTRUS REUSABLE CIRCULAR STAPLER AND DISPOSABLE RELOADS | 08/03/2011 |
| K062869 | ETHICON ENDO-SURGERY, LLC | CONTOUR CURVED CUTTER STAPLER AND RELOADS, MODELS CS40B, CS40G, CR40B AND CR40G | 02/26/2007 |
| K112056 | ETHICON ENDO-SURGERY, LLC | ECHELON 60 ENDOSCOPIC LINEAR CUTTER RELOAD, BLACK MODEL ECR60T, ECHELON 45 ENDOSCOPIC LINEAR CUTTER RELOAD, BLACK MODEL | 12/19/2011 |
| K121600 | ETHICON ENDO-SURGERY, LLC | ECHELON 60 ENDOSCPIC LINEAR CUTTER RELOAD, WHITE | 07/16/2012 |
| K163523 | Ethicon Endo-Surgery, LLC | ECHELON CIRCULAR Powered Stapler | 04/18/2017 |
| K200420 | Ethicon Endo-Surgery, LLC | Echelon Contour Curved Cutter with blue reload, Echelon Contour Curved Cutter with green reload, Echelon Contour Curved Cutter reload, Blue, Echelon Contour Curved Cutter reload, Green | 06/29/2020 |
| K131663 | ETHICON ENDO-SURGERY, LLC | ECHELON ENDOSCOPIC LINEAR CUTTER RELOAD, BLACK | 10/18/2013 |
| K183435 | Ethicon Endo-Surgery, LLC | Echelon Endoscopic Linear Cutter Reloads, White, Blue, Gold, Green and Black | 02/06/2019 |
| K081146 | ETHICON ENDO-SURGERY, LLC | ECHELON ENDOSCOPIC LINEAR CUTTERS (ARTICULATING AND STRAIGHT) | 06/26/2008 |
| K130653 | ETHICON ENDO-SURGERY, LLC | ECHELON FLEX 45 POWERED ARTICULATING ENDOSCOPIC LINEAR CUTTER; ECHELON FLEX 60 POWERED ARTICULATING ENDOSCOPIC LINEAR CU | 03/29/2013 |
| K163454 | ETHICON ENDO-SURGERY, LLC | ECHELON FLEX 45mm Powered Plus Articulating Endoscopic Linear Cutters, ECHELON ENDOPATH Endoscopic Linear Cutter Reloads, 45mm | 01/05/2017 |
| K202665 | Ethicon Endo-Surgery, LLC | Echelon Flex 45mm Powered Plus Articulating Endoscopic Linear cutters, Echelon Flex 60mm Powered Plus Articulating Endoscopic Linear cutters, Echelon Endopath Endoscopic Linear Cutter Reloads, 45mm, Echelon Endopath Endoscopic Linear Cutter Reloads, 60mm | 10/15/2020 |
| K160521 | ETHICON ENDO-SURGERY, LLC | ECHELON FLEX 60 Powered Plus Compact Articulating Endoscopic Linear Cutter, 280mm | 03/22/2016 |
| K140560 | ETHICON ENDO-SURGERY, LLC | ECHELON FLEX POWERED PLUS ARTICULATING ENDOSCOPIC LINEAR CUTTER, 60MM, STANDARD, ECHELON FLEX POWERED PLUS ARTICULATING | 04/22/2014 |
| K080839 | ETHICON ENDO-SURGERY, LLC | ECHELON GRAY CARTRIDGE, MODEL ERC45M | 05/21/2008 |
| K111111 | ETHICON ENDO-SURGERY, LLC | ENDOPATH ETS 35MM ENDOSCOPIC LINEAR CUTTER AND RELOADS, AND ETS-FLEX 35MM ENDOSCOPIC ARTICULATING LINEAR CUTTER AND RELO | 06/08/2011 |
| K070887 | ETHICON ENDO-SURGERY, LLC | ENDOPATH LINEAR CUTTERS AND STAPLERS AND ECHELON60 ENDOSCOPIC LINEAR CUTTERS AND STAPLERS (AND RELOADS) | 05/25/2007 |
| K181653 | Ethicon Endo-Surgery, LLC | Ethicon Circular Stapler, Ethicon Circular Stapler -XL Sealed | 09/18/2018 |
| K092577 | ETHICON ENDO-SURGERY, LLC | ETHICON ENDO-SURGERY LINEAR CUTTER 55MM (NTLC55),SELECTABLE CARTRIDGE 55 / 75MM (SR55/75) ,LINEAR CUTTER 75MM (NTLC75) | 09/15/2009 |
| K110049 | ETHICON ENDO-SURGERY, LLC | REUSABLE LINEAR STAPLER HANDLE | 02/10/2011 |
| K103672 | ETHICON ENDO-SURGERY, LLC | REUSABLE PPH CIRCULAR STAPLER HANDLE, PPH CIRCULAR STAPLER RELOAD & ACCESSORY SET | 04/08/2011 |
| K093845 | ETHICON, INC. | ETHICON SECURESTRAP 5MM ABSORBABLE STRAP FIXATION DEVICE, MODEL STRAP25 | 04/07/2010 |
| K123114 | ETHICON, INC. | ETHICON SECURESTRAP OPEN ABSORBABLE STRAP FIXATION DEVICE | 02/05/2013 |
| K181620 | Ezisurg (Suzhou) Medical Co., Ltd. | Endoscopic Linear Cutting Staplers and Loading Units for Single Use | 09/18/2018 |
| K182217 | Ezisurg (Suzhou) Medical Co., Ltd. | Linear Cutter Staplers and Loading Units for Single Use, Circular Staplers for Single Use | 04/16/2019 |
| K210909 | Ezisurg Medical Co., Ltd. | easyEndo Lite Linear Cutting Stapler and Loading Unit for Single Use | 06/24/2021 |
| K172960 | Ezisurg Medical Co., Ltd. | easyEndoTM Linear Cutting Stapler and Loading Units for Single Use, easyEndoTM Universal Linear Cutting Stapler and Loading Units for Single Use | 12/21/2017 |
| K181657 | Ezisurg Medical Co., Ltd. | easyLCTM Linear Cutter Staplers and Loading Units fot Single Use; easyCSTM Circular Stapler for Single Use | 02/01/2019 |
| K183477 | Ezisurg Medical Co., Ltd. | easyPPHTM Hemorrhoidal Stapler for Single Use | 02/11/2019 |
| K143129 | EziSurg Medical Co.,Ltd. | easyEndo Linear Cutting Stapler and Loading Unit for Single Use(Stapler;Loading Unit) | 01/29/2015 |
| K202467 | Fengh Medical Co., Ltd. | Disposable Powered Articulating Endoscopic Linear Cutter Stapler & Reloads | 12/14/2020 |
| K182476 | Fengh Medical Co., Ltd. | Disposable Powered Articulating Endoscopic Linear Cutter Stapler & Reloads | 12/18/2019 |
| K090821 | FRANKENMAN INTERNATIONAL LIMITED | CHEX SINGLE USE CURVED INTRALUMINAL CIRCULAR STAPLER, MODEL CS 21, CS 25, CS 28, CS 32, CS 21L, CS 25L, CS 28L, CS 32L | 06/10/2009 |
| K983318 | GENERAL SURGICAL INNOVATIONS | FIXATION SYSTEM | 03/01/1999 |
| K162707 | Golden Stapler Surgical Co., Ltd. | Single Use Circular Stapler, Single Use Hemorrhoidal Circular Stapler, Single Patient Use Linear Stapler and Reload, Single Patient Use Linear Cutter and Reload, Single Patient Use Endo Cutter and Reload, Single Patient Use Transverse Cutter and Reload | 07/14/2017 |
| K061784 | INCISIVE SURGICAL, INC. | INSORB ABSORBABLE STAPLE, MODEL 1020 | 07/26/2006 |
| K090159 | INCISIVE SURGICAL, INC. | INSORB ABSORBABLE STAPLE, MODEL 1020, 1025, AND OTHER PRODUCT FAMILIES | 02/06/2009 |
| K033602 | INCISIVE SURGICAL, INC. | INSORB ABSORBABLE STAPLE, MODEL SP-B20 | 12/16/2003 |
| K024117 | INCISIVE SURGICAL, INC. | INSORB ABSORBABLE STAPLES, MODEL SP-B20 | 04/22/2003 |
| K120373 | INCISIVE SURGICAL, INC. | INSORB ABSORBALBE STAPLE | 03/16/2012 |
| K041201 | INRAD | ULTRACLIP II MR | 06/03/2004 |
| K993785 | INRAD | ULTRACLIP TISSUE MARKER | 02/04/2000 |
| K041159 | JMS, INC. | JMS ABSORBABLE ANCHOR AND APPLICATOR | 07/27/2004 |
| K132472 | JUSTRIGHT SURGICAL, LLC | JUSTRIGHT 5MM STAPLER, JUSTRIGHT 5MM RELOAD | 02/11/2014 |
| K101961 | LAAX, INC. | TIGERPAW SYSTEM | 10/29/2010 |
| K111064 | LAAX, INC. | TIGERPAW SYSTEM II | 05/18/2011 |
| K171589 | Lexington Medical Inc. | AEON Endoscopic Stapler | 11/17/2017 |
| K173443 | Lexington Medical Inc. | AEON Endoscopic Stapler | 02/01/2018 |
| K201882 | Lexington Medical Inc. | AEON Endoscopic Stapler | 10/09/2020 |
| K222210 | Lexington Medical Inc. | AEON Endoscopic Stapler | 04/21/2023 |
| K182380 | Lexington Medical, Inc. | AEON Endoscopic Stapler | 11/28/2018 |
| K200320 | M/s. Meril Endo Surgery Private Limited | Mirus Circular Stapler, Mirus Linear Cutter and Reload, Mirus Hemorrhoidal Circular Stapler, Mirus Linear Stapler and Reload | 02/05/2021 |
| K023725 | MARINA MEDICAL INSTRUMENTS, INC. | HEMORRHAGE OCCLUDER PIN (HOP), MODEL 337-247 | 02/03/2003 |
| K060494 | MEDCHANNEL, LLC | EASYTAC ANCHOR. EASYTAC DELIVERY SYSTEM | 07/03/2006 |
| K130738 | NANJING MAIDIXIN MEDICAL DEVICE CO., LTD. | ENDOSCOPIC LINEAR CUTTING STAPLERS WITH SINGLE USE LOADING UNITS | 12/13/2013 |
| K211458 | Ningbo VeryKind Medical Device Co., Ltd. | Disposable Anorectal Staplers, Disposable Intraluminal Staplers, Disposable Linear Cutting Staplers, Disposable Endoscopic Cutting Staplers | 12/30/2021 |
| K202709 | Ningbo Verykind Medical Device Co., Ltd. | Disposable Powered Endoscopic Linear Cutting Staplers and Cartridges | 05/18/2021 |
| K042492 | NITI MEDICAL TECHNOLOGIES LTD. | HAND STC, MODEL 60MM | 10/19/2004 |
| K003522 | ONUX MEDICAL, INC. | SALUTE | 02/13/2001 |
| K014286 | ONUX MEDICAL, INC. | SALUTE, MODEL 3022 | 03/08/2002 |
| K131563 | OPUS KSD, INC. | SUBQ IT! BIOABSORBABLE SKIN CLOSURE SYSTEM | 04/09/2014 |
| K071708 | POWER MEDICAL INTERVENTIONS, INC. | I45, I45S, I60, AND I60S | 09/27/2007 |
| K073001 | POWER MEDICAL INTERVENTIONS, INC. | IDRIVES, IDRIVEC, IDRIVEF | 12/18/2007 |
| K073148 | POWER MEDICAL INTERVENTIONS, INC. | IDRIVES, IDRIVEC, IDRIVEF WITH VASCULAR INDICATIONS | 12/07/2007 |
| K083527 | POWER MEDICAL INTERVENTIONS, INC. | INTELLIGENT ARTICULATING ENDOSCOPIC LINEAR CUTTER REVERSE WITH RELOADS | 12/18/2008 |
| K091215 | POWER MEDICAL INTERVENTIONS, INC. | INTELLIGENT POWER UNIT, INTELLIGENT CONSOLE, INTELLIGENT DELIVERY SYSTEM, INTELLIGENT SURGICAL INSTRUMENT | 05/18/2009 |
| K081826 | POWER MEDICAL INTERVENTIONS, INC. | INTELLIGENT STRAIGHT AND ARTICULAR ENDOSCOPIC LINEAR CUTTERS, VASCULAR WITH RELOADS, MODELS I30V, I45V, 160V, IR30V | 07/25/2008 |
| K063075 | POWER MEDICAL INTERVENTIONS, INC. | NATURAL ORIFICE LINEAR CUTTER DIGITAL LOADING UNITS | 11/02/2006 |
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