FDA 510(k) Applications for Medical Device Product Code "KNS"
(Unit, Electrosurgical, Endoscopic (With Or Without Accessories))
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K212999 | Anrei Medical (Hangzhou) Co., Ltd. | Multi-Functional Electrosurgical Knife | 03/21/2022 |
| K082114 | APOLLO ENDOSURGERY, INC. | ELECTROCAUTERY DILATION BALLOON, MODELS: EDB-0018-00, EDB-0020-00, EDB-0022-00 | 12/19/2008 |
| K183595 | Aqua Medical, Inc. | Aqua Medical RF Vapor System | 06/21/2019 |
| K211282 | Aqua Medical, Inc. | Aqua Medical RF Vapor System | 05/27/2021 |
| K213627 | Aqua Medical, Inc. | RF Vapor System | 12/17/2021 |
| K000508 | ARGOMED, INC. | THERMOFLEX SYSTEM | 04/18/2000 |
| K991847 | ARGOMED, INC. | THERMOFLEX SYSTEM | 08/26/1999 |
| K010568 | ARTHROCARE CORP. | ARTHROCARE UROLOGY ELECTROSURGERY SYSTEM | 03/27/2001 |
| K990376 | BALLARD MEDICAL PRODUCTS | BALLARD MEDICAL PRODUCTS FACILETOME BOW STRING PAPILLOTOME | 05/03/1999 |
| K963484 | BARD INTERVENTIONAL PRODUCTS DIV. | BARD HIGH FLOW PAPILLOTOME | 11/19/1996 |
| K982557 | BARD INTERVENTIONAL PRODUCTS DIV. | BARD PROFORMA AND APOLLO PRE-CURVED PAPILLOTOMES | 09/10/1998 |
| K013153 | BOSTON SCIENTIFIC CORP. | AUTOTOME RX MODEL # 4515, 4516 | 10/19/2001 |
| K961349 | BOSTON SCIENTIFIC CORP. | INJECTION GOLD PROBE | 05/15/1996 |
| K970278 | BOSTON SCIENTIFIC CORP. | MICROVASIVE GOLD PROBE | 04/11/1997 |
| K002802 | BOSTON SCIENTIFIC CORP. | RAPID EXCHANGE TAPERTOME | 10/05/2000 |
| K973826 | BOSTON SCIENTIFIC CORP. | SPHINCTEROTOME | 12/05/1997 |
| K122203 | BOSTON SCIENTIFIC CORP. | TRUETOME | 08/17/2012 |
| K970053 | BOSTON SCIENTIFIC CORP. | ULTRATOMERX | 03/28/1997 |
| K232162 | Boston Scientific Corporation | Autotome Pro RX 39 Sphincterotome; Autotome Pro RX 44 Sphincterotome; Jagtome Pro RX 44 Sphincterotome; Jagtome Pro RX 39 Sphincterotome; Dreamtome Pro RX 44 Sphincterotome; Hydratome Pro RX 44 Sphincterotome; Jagtome Revolution Pro RX 39 Sphincterotome | 08/14/2023 |
| K231533 | Boston Scientific Corporation | Habib EndoHPB | 06/21/2023 |
| K110887 | Boston Scientific Corporation | INJECTION GOLD PROBE BIPOLAR ELECTROHEMOSTASIS CATHETER | 04/14/2011 |
| K133933 | Boston Scientific Corporation | INJECTION GOLD PROBE BIPOLAR ELECTROHEMOSTASIS CATHETER | 04/02/2014 |
| K200404 | Boston Scientific Corporation | ORISE ProKnife | 12/03/2020 |
| K080946 | CONMED ENDOSCOPIC TECHNOLOGIES, INC. | CONMED AXCESS PAPILLOTOME MODELS AX4535, AX4535FX | 05/20/2008 |
| K050578 | COOK IRELAND LTD | COOK IRELAND DUETTE MULTI-BAND MUCOSECTOMY DEVICE | 04/22/2005 |
| K990850 | COOPERSURGICAL, INC. | COOPERSURGICAL COAGULATOR FOR TATTOO REMOVAL | 06/01/1999 |
| K990852 | COOPERSURGICAL, INC. | COOPERSURGICAL INFRARED COAGULATOR | 06/11/1999 |
| K990855 | COOPERSURGICAL, INC. | COOPERSURGICAL INFRARED COAGULATOR FOR ENT | 03/30/1999 |
| K130623 | Covidien LLC | BARRX CHANNEL RFA ENDOSCOPIC CATHETER | 07/26/2013 |
| K173559 | Covidien llc | Barrx SB RFA Endoscopic Catheter | 01/18/2018 |
| K171983 | Creo Medical Ltd | Creo Medical Electrosurgical System including Speedboat RS2 Surgical Accessory | 08/17/2017 |
| K192905 | Creo Medical Ltd. | Creo Electrosurgical System with HS1 Hemostasis Accessory | 03/19/2020 |
| K180165 | EMcision Ltd. | Habib EndoHPB | 03/20/2018 |
| K072383 | EMCISION, LTD. | HABIB ENDOBLATE | 11/29/2007 |
| K083292 | EMCISION, LTD. | HABIB ENDOHPB | 06/10/2009 |
| K031026 | ENDO-THERAPEUTICS, INC. | ETI BIPOLAR HEMOSTATIC PROBE | 06/27/2003 |
| K021266 | ETHICON ENDO-SURGERY, INC. | ENDO WINDOW HIGH FREQUENCY ELECTROCAUTERY DEVICE, MODEL EW018 | 09/27/2002 |
| K211909 | G-Flex Europe SPRL | Cysto-Gastro-Sets | 06/09/2022 |
| K092571 | GYRUS ACMI, INC. | GYRUS ACMI BIOCOAG PROBE | 10/20/2010 |
| K990628 | GYRUS MEDICAL LTD. | GYRUS ENDOUROLOGY SYSTEM | 06/29/1999 |
| K994166 | GYRUS MEDICAL LTD. | GYRUS ENDOUROLOGY SYSTEM: AXIPOLAR RESECTOSCOPE ELECTRODE | 12/27/1999 |
| K003569 | GYRUS MEDICAL LTD. | PLASMAKINETIC ENDOUROLOGY SYSTEM | 12/19/2000 |
| K192342 | Hangzhou AGS MedTech Co., Ltd. | Electrosurgical System (Electrosurgical Generator with Bipolar polypectomy snare combination and Single use electrosurgical knife combination accessories) | 05/21/2020 |
| K222421 | Hangzhou AGS MedTech Co., Ltd. | Sphincterotome | 05/03/2023 |
| K201121 | Hangzhou AGS MedTech Co., Ltd. | Sphincterotome | 02/05/2021 |
| K093079 | HOBBS MEDICAL, INC. | TOUCHSOFT COAGULATOR WITH BANANA FITTING, MODEL 4581 AND WITH UNIVERSAL FITTING, MODEL 4581-U | 08/02/2010 |
| K974168 | HOGAN & HARTSON | COOPERSURGICAL INFRARED COAGULATOR | 01/23/1998 |
| K002236 | HORIZONS INTL. CORP. | HORIZONS PAPILLOTOME | 01/23/2001 |
| K962083 | KARL STORZ ENDOSCOPY-AMERICA, INC. | KARL STORZ REMORGIDA FORCEPS | 11/01/1996 |
| K222542 | Lamidey Noury Medical | MCB UNIT Model: V10GMCBUS | 09/21/2022 |
| K960231 | LIGHTHOUSE MEDICAL, INC. | SPHINCTEROTOME | 07/31/1996 |
| K083275 | MAX ENDOSCOPY INC. | PRECISION ENDOSCOPIC INFRARED COAGULATOR; MODEL 5100 SINGLE- USE DISPOSABLE MAXI-GUIDE FLEXIBLE LIGHTGUIDE; MODEL 5100-2 | 06/09/2009 |
| K061684 | MEDI-GLOBE CORPORATION | MEDI-GLOBE ROTA-CUT SPHINCTEROTOME | 06/27/2006 |
| K082464 | MEDTRONIC INC. | PROSTIVA RF THERAPY HAND PIECE, MODEL 8929 | 10/27/2008 |
| K101139 | MEDTRONIC INC. | PROSTIVA RF THERAPY MODEL 8929 HAND PIECE | 05/21/2010 |
| K052413 | MEDTRONIC VASCULAR | TUNA SYSTEM, MODELS 8909, 8929, 8930, 8934 | 11/17/2005 |
| K102273 | MERIT MEDICAL SYSTEMS, INC. | MERIT BIPOLAR COAGULATION PROBE | 09/07/2010 |
| K210934 | Micro-Tech (Nanjing) Co., Ltd. | Sphincterotome / short-wire compatible, Sterile Sphincterotome | 12/01/2021 |
| K190093 | NxThera (A Boston Scientific Company) | Rezum Delivery Device, Rezum Generator | 03/25/2019 |
| K191505 | NxThera (A Boston Scientific Company) | Rezum System | 08/02/2019 |
| K180237 | NxThera, Inc. | Rezum System | 02/27/2018 |
| K160417 | NxThera, Inc. | Rezum System | 03/17/2016 |
| K150786 | NxThera, Inc. | Rezum System | 08/27/2015 |
| K982289 | OLYMPUS AMERICA, INC. | HEAT PROBE UNIT HPU-20, HEAT PROBE CD-110##/120## | 08/19/1998 |
| K955247 | OLYMPUS AMERICA, INC. | OLYMPUS KD SERIES SPHINCTEROTOME | 04/30/1996 |
| K141991 | OLYMPUS MEDICAL SYSTEMS COPR. | SINGLE USE PRELOADED SPHINCTEROTOME V (DISTAL WIREGUIDED); SINGLE USE SP | 03/31/2015 |
| K150142 | OLYMPUS MEDICAL SYSTEMS CORP. | Single Use Balloon Dilator V (with Knife) | 10/08/2015 |
| K193039 | Olympus Medical Systems Corp. | Single Use Balloon Dilator V (with knife) | 12/17/2019 |
| K171158 | Olympus Medical Systems Corp. | Single Use Electrosurgical knife | 11/17/2017 |
| K182408 | Olympus Medical Systems Corp. | Single Use Electrosurgical Knife KD-625 , Single Use Electrosurgical Knife KD-645 | 05/15/2019 |
| K122505 | OLYMPUS MEDICAL SYSTEMS CORP. | SINGLE USE PRELOADED SPHINCTEROTOME V | 04/11/2013 |
| K160241 | OLYMPUS MEDICAL SYSTEMS CORP. | Single Use Sphincterotome V (Distal Wireguided) KD-VC412Q-0215 | 03/02/2016 |
| K092309 | OLYMPUS MEDICAL SYSTEMS CORPORATION | SINGLE USE ELECTROSURGICAL KNIFE SERIES, MODEL KD-610L, KD-611L, KD-620LR, KD-630L, KF-640L | 10/30/2009 |
| K123319 | OLYMPUS SURGICAL TECHNOLOGIES AMERICA | GYRUS ACMI BICOAG HEMOSTASIS PROBE | 12/14/2012 |
| K181758 | STARmed Co., Ltd. | ELRA Electrode | 04/11/2019 |
| K033135 | Stryker Endoscopy | STRYKER WIRELESS UNIVERSAL FOOTSWITCH SYSTEM | 08/09/2004 |
| K190621 | Sumitomo Bakelite Co., Ltd | SB Knife/Short type, SB Knife/Standard type, SB Knife/Jr type, SB Knife/Jr type - Long | 04/23/2019 |
| K152771 | SUMITOMO BAKELITE CO., LTD. | SB Knife Jr type, SB Knife Short type, SB Knife Standard type, SB Knife Jr type - Long | 06/17/2016 |
| K223256 | Taewoong Medical Co., Ltd. | OptimosÖ Cystotome | 04/05/2023 |
| K992402 | TELEMED SYSTEMS, INC. | 5.0 FRENCH X 200CM X 35MM TIP TAPER-20MM CUTTING WIRE, 5.0 FRENCH X 200CM X 35MM TIP TAPER-30MM CUTTING WIRE, 5.0 FRENCH | 12/22/1999 |
| K030194 | THE OLYMPUS OPTICAL CO. | XUES-41 ENDOSCOPIC ELECTROSURGICAL UNIT | 03/24/2003 |
| K030315 | ULTROID, LLC | MODIFICATION TO ULTROID HEMORRHOID MANAGEMENT SYSTEM | 02/27/2003 |
| K023706 | ULTROID, LLC | ULTROID HEMORRHOID MANAGEMENT SYSTEM | 01/14/2003 |
| K970945 | UNITED STATES ENDOSCOPY GROUP, INC. | ANGLED TIP POLYPECTOMY SNARE | 05/07/1997 |
| K962346 | UNITED STATES ENDOSCOPY GROUP, INC. | PAPILLOTOME | 08/08/1996 |
| K961762 | UNITED STATES ENDOSCOPY GROUP, INC. | REUSABLE ENDOSCOPIC ACCESSORY HANDLE | 07/22/1996 |
| K973366 | VIDAMED, INC. | COBRA HAND PIECE | 11/26/1997 |
| K011787 | VIDAMED, INC. | PRECISION TUNA OFFICE SYSTEM WITH NO RECTAL TEMPERATURE MONITORING TAPE | 07/06/2001 |
| K012587 | VIDAMED, INC. | RF GENERATORS, DISPOSABLE CARTRIDGE KIT, DISPOSABLE CARTRIDGE, REUSABLE HANDLE, DISOISABLE HANDPIECE REUSABLE TELESCOPE | 12/11/2001 |
| K002583 | VIDAMED, INC. | TUNA (TRANS URETHRA NEEDLE) OFFICE SYSTEM | 02/13/2001 |
| K052051 | WILSON-COOK MEDICAL, INC. | OMNI SPHINCTEROTOME | 08/05/2005 |
| K192339 | Wilson-Cook Medical, Inc. | TeslaTome Bipolar Sphincterotome, Tesla Bipolar Active Cord | 01/30/2020 |
| K040981 | WILSON-COOK MEDICAL, INC. | USW NEEDLEKNIFE PAPILLOTOME | 05/07/2004 |
| K990145 | WILSON-COOK MEDICAL, INC. | WILSON-COOK BIPOLAR PROBE | 03/25/1999 |
| K022595 | WILSON-COOK MEDICAL, INC. | WILSON-COOK CYSTOTOME | 10/17/2002 |
| K972674 | WILSON-COOK MEDICAL, INC. | WILSON-COOK NEEDLE KNIFE PAPILLOTOME | 08/15/1997 |
| K033203 | WILSON-COOK MEDICAL, INC. | WILSON-COOK TRI-TOME SELECT PLUS | 12/19/2003 |
| K172665 | Wilson-Cook Medical, Inc. / Cook Endoscopy | Classic Cotton Cannulatome«, CannulaTome II« Double Lumen Sphincterotome, Cotton CannulaTome II« PC, UTS« Ultra Taper Sphincterotome, Tri-Tome pc« Triple Lumen Sphincterotome, Howell D.A.S.H.« Sphincterotome with DomeTip«, Billroth II Sphincterotome, Soeh | 05/24/2018 |
| K171993 | Wilson-Cook Medical, Inc. / Cook Endoscopy | Zimmon Needle Knife Papillotome | 08/17/2017 |
| K172288 | Wilson-Cook Medical, Inc./ Cook Endoscopy | Fusion OMNI Sphincterotome | 04/17/2018 |
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