FDA 510(k) Applications for Medical Device Product Code "KNW"
(Instrument, Biopsy)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K052638 | ABBOTT SPINE, INC. | ABBOTT SPINE, INC. SPINNAKER SYSTEM | 11/07/2005 |
| K032847 | ACUEITY, INC. | EXCISOR BIOPTOME, MODEL 01-0004 | 09/26/2003 |
| K003370 | ALLEGIANCE HEALTHCARE CORP. | JAMSHIDI MARROW ACQUISITION CRADLE | 11/22/2000 |
| K121181 | ALLIANCE PARTNERS, LLC | SWANNSHIDI BONE MARROW ASPIRATION NEEDLE | 08/22/2012 |
| K193268 | AprioMed AB | APrioCore Plus | 02/27/2020 |
| K150625 | APRIOMED AB | Morrison Steerable Needle | 06/09/2015 |
| K213232 | Argon Medical Devices | NovaCore Semi-Automatic Biopsy Instrument | 07/01/2022 |
| K020024 | ARTEMIS MEDICAL, INC. | CARIS MINITOME BIOPSY INSTRUMENT | 04/03/2002 |
| K213213 | Arthrex Inc. | Arthrex Vortex Threaded Bone Marrow Recovery Needle | 11/19/2021 |
| K152474 | Avitus Orthopaedics Inc. | Avitus Bone Harvester | 10/23/2015 |
| K170539 | Avitus Orthopaedics, Inc | Avitus Bone Harvester with Filter Insert - 5mm, Avitus Bone Harvester - 5mm, Avitus Bone Harvester with Filter Insert - 8mm, Avitus Filter Insert - 8mm, Avitus Filter Insert - 5mm | 03/20/2017 |
| K210631 | Avitus Orthopaedics, Inc. | Avitus(r) Bone Harvester | 03/31/2021 |
| K213896 | Bard Peripheral Vascular | BD Trek Powered Bone Biopsy System | 03/30/2022 |
| K211933 | Bard Peripheral Vascular | EleVation Breast Biopsy System | 07/15/2021 |
| K171953 | Bard Peripheral Vascular, Inc. | Bard Mission Disposable Core Biopsy Instrument | 09/14/2017 |
| K133948 | BARD PERIPHERAL VASCULAR, INC. | BARD(R) MONOPTY(R) DISPOSABLE CORE BIOPSY INSTRUMENT, BARD(R) MAX-CORE(R) DISPOSABLE CORE INSTRUMENT | 02/21/2014 |
| K192948 | Bard Peripheral Vascular, Inc. | EleVation Breast Biopsy Driver, EleVation Breast Biopsy Probe - 10G, EleVation Breast Biopsy Probe - 14G | 11/07/2019 |
| K960064 | BAUER MEDICAL, INC. | TEMNO ACHIEVE BIOPSY NEEDLE | 04/05/1996 |
| K960065 | BAUER MEDICAL, INC. | TEMNO DOUBLE SHOT BIOPSY NEEDLE | 04/05/1996 |
| K960509 | BAXTER HEALTHCARE CORP. | 18 GAUGE TRU-CUT BIOPSY NEEDLE | 04/04/1996 |
| K963390 | BAXTER HEALTHCARE CORP. | BIOPSY INTRODUCER NEEDLE | 10/10/1996 |
| K962907 | BAXTER HEALTHCARE CORP. | SKINNY,FRANSEEN,WESCOTT NEEDLES | 10/23/1996 |
| K120189 | BERNI FARNS INCORPORATED | BONETRAP | 02/22/2012 |
| K141910 | BIOLOGIC THERAPIES INC | Intraosseous Cannula System Bio-MAC┐ and Bio-CORE | 05/04/2015 |
| K190378 | Bioncise NV | Spirotome Endo 08 Gauge, Spirotome Endo 10 Gauge, Spirotome Endo 14 Gauge, Spirotome Endo 14 Gauge with 10 mm Helix | 05/24/2019 |
| K011104 | BIOPSYBELL S.A.S. | OSTEOBELL | 05/31/2001 |
| K010735 | BIOPSYBELL S.A.S. | SPEEDYBELL | 08/17/2001 |
| K130616 | BIOPSYBELL S.R.L. | MANUAL-BONE-MARROW-BIOPSY-NEEDLES, SEMI-AUTOMATIC-BIOPSY-NEEDLES, AUTOMATIC-BIOPSY-NEEDLES | 02/07/2014 |
| K203397 | Biopsybell s.r.l. | Marrow-Pack (white)- 11gauge/10cm or 13gauge/10cm, Marrow-Tray (red)- 11gauge/10cm or 13gauge/10cm, Marrow-Set (violet)- 11gauge/10cm or 13gauge/10cm, Marrow-kit (grey)- 11gauge/10cm or 13gauge/10cm, Marrow-Stem (green)- 11gauge/10cm or 13gauge/10cm | 01/11/2021 |
| K970565 | BIOPSYS MEDICAL, INC. | MAMMOTOME BIOPSY PROBE AND HOUSING (MAMMOTOME) | 03/28/1997 |
| K024089 | BIP USA, INC. | VACUFLASH BIOPSY SYSTEM | 03/11/2003 |
| K051361 | BOSTON SCIENTIFIC CORP. | EASY CORE DETACHABLE BIOPSY SYSTEM | 06/16/2005 |
| K110883 | BUSSE HOSPITAL DISPOSABLES | J-STYLE BONE MARROW BIOPSY / ASPIRATION NEEDLE WITH SNARE-IT MARROW ACQUISITION CANNULA | 06/08/2011 |
| K061570 | BUSSE HOSPITAL DISPOSABLES, INC. | I-STYLE BONE MARROW ASPIRATION NEEDLE | 07/03/2006 |
| K120002 | BUSSE HOSPITAL DISPOSABLES, INC. | I-STYLE BONE MARROW ASPIRATION NEEDLE WITH T-HANDLE | 06/26/2012 |
| K962077 | C.R. BARD, INC. | BARD BIOPTY-CUT BIOPSY NEEDLE/WITH SPACER | 07/30/1996 |
| K111100 | C.R. BARD, INC. | ENCOR ENSPIRE BREAST BIOPSY SYSTEM | 06/16/2011 |
| K103359 | C.R. BARD, INC. | FINESSE ULTRA BREAST BIOPSY SYSTEM DRIVER (BLUE, PINK) | 12/27/2010 |
| K093068 | C.R. BARD, INC. | FINESSE ULTRA BREAST BIOSPY SYSTEM DRIVER - BLUE, PINK, PROBE FO1BLU, FOIPNK, F14105US | 11/10/2009 |
| K062832 | C.R. BARD, INC. | VACORA 14G BIOPSY PROBES, MODELS VB14116, VB14138 | 10/20/2006 |
| K082681 | C.R. BARD, INC. | VACORA VACUUM ASSISTED BIOPSY SYSTEM | 10/15/2008 |
| K222865 | Canyon Medical Inc. | M Biopsy /SureCore Automatic Disposable Biopsy Needle, M Biopsy /SureCore Semi-Automatic Disposable Biopsy Needle, M Biopsy /SureAim Coaxial Biopsy Needle | 04/03/2023 |
| K070091 | CARDINAL HEALTH, INC. | COAXIAL BONE AND VERTEBRAL BODY BIOPSY NEEDLE MODEL# JBC1213, JBC1208 | 04/18/2007 |
| K141552 | CAREFUSION | ACHIEVE PROGRAMMABLE AUOMATED BIOPSY SYSTEMS | 09/05/2014 |
| K171531 | CareFusion | Jamshidi Bone Marrow Biopsy/Aspiration Needle, Jamshidi T-Handle Bone Marrow Biopsy/Aspiration Needle, Jamshidi Evolve Bone Marrow Biopsy/Aspiration Needle | 09/11/2017 |
| K102756 | CHEST INNOVATIONS INC | SURECORE BIOPSY DEVICE | 11/29/2011 |
| K002546 | CIVCO MEDICAL INSTRUMENTS CO., INC. | CIV-FLEX HOLSTER COVER, MODEL STERILE, LATEX-FREE | 10/31/2000 |
| K170008 | COOK INCORPORATED | Osteo-Site Bone Biopsy Needle, Osteo-Site Bone Biopsy Needle Set | 02/28/2017 |
| K973565 | COOK, INC. | QUICK-CARE BIOPSY NEEDLE | 11/03/1997 |
| K974575 | DAUM CORP. | DAUM ASPIRATIONBIOPSY NEEDLE | 03/06/1998 |
| K974576 | DAUM CORP. | DAUM BIOPSYGUN | 03/06/1998 |
| K981320 | DAUM CORP. | DAUM BONE BIOPSY SET | 06/29/1998 |
| K974631 | DAUM CORP. | DAUM NEUROBIOPSY NEEDLE | 03/09/1998 |
| K990278 | DAUM CORP. | DAUM NEUROCUT NEUROBIOPSYNEEDLE | 03/30/1999 |
| K974574 | DAUM CORP. | DAUM NEUROPUNCTURE NEEDLE | 03/06/1998 |
| K010037 | DAUM GMBH | DAUM DOUBLE-SHOOT BISOPSY GUN | 03/22/2001 |
| K991366 | DAUM GMBH | DAUM MRI/CONVENTIONAL BIOPSY KIT | 06/25/1999 |
| K990782 | DAUM GMBH | DAUM NEUROGATE TROCAR | 04/28/1999 |
| K112411 | DEVICOR MEDICAL PRODUCTS INC. | MAMMOTOME ELITE BIOPSY SYSTEM | 03/20/2012 |
| K153709 | DEVICOR MEDICAL PRODUCTS, INC. | Mammotome elite Biopsy System-13G Probe, Mammotome elite Biopsy System-10G Probe, Mammotome elite Biopsy System-Holster, Mammotome elite Biopsy System-13G Introducer Stylet, Mammotome elite Biopsy System-10G Introducer Stylet | 08/08/2016 |
| K123259 | DEVICOR MEDICAL PRODUCTS, INC. | MAMMOTOME REOLVE DUAL VACUUM ASSISTED BIOPSY (VAB) SYSTEM | 11/15/2012 |
| K152989 | DEVICOR MEDICAL PRODUCTS, INC. | Mammotome revolve Dual Vacuum Assist Biopsy System | 02/25/2016 |
| K202012 | Devicor Medical Products, Inc. | Mammotome Revolve Dual Vacuum Assisted Biopsy (VAB) System | 08/18/2020 |
| K003528 | ENDOCARE, INC. | SANARUS CORE TISSUE BIOPSY SYSTEM | 05/03/2001 |
| K992813 | ETHICON ENDO-SURGERY, INC. | 11 GAUGE PROBE, STEREOTACTIC, 14 GAUGE PROBE, STEREOTACTIC,14 GAUGE PROBE, ULTRASOUND, HOUSING STEREOTACTIC,HOUSING, ULT | 11/18/1999 |
| K030472 | ETHICON ENDO-SURGERY, INC. | MAMMOTOME BIOPSY SYSTEM PROBE & HOUSING, MAMMOTOME HAND-HELD SYSTEM | 10/09/2003 |
| K033700 | ETHICON ENDO-SURGERY, INC. | MAMMOTOME EX HAND HELD SYSTEM | 02/20/2004 |
| K003297 | ETHICON ENDO-SURGERY, INC. | MAMMOTOME HAND HELD PROBE, MODEL MHH8 | 01/18/2001 |
| K991980 | ETHICON ENDO-SURGERY, INC. | MAMMOTOME HH HAND-HELD PROBE, VACUUM SET, CONTROL MODULE, HH HAND-HELD HOLSTER AND CABLES, SOFTWARE PACKAGE, FOOTSWITCH, | 08/17/1999 |
| K042753 | ETHICON ENDO-SURGERY, INC. | MAMMOTOME MR BIOPSY SYSTEM | 11/08/2004 |
| K093899 | ETHICON ENDO-SURGERY, LLC | MAMMOTOME BIOPSY SYSTEM FOR MOLECULAR IMAGING | 04/29/2010 |
| K963794 | FERGUSON MEDICAL | PUNCTURENEEDLE | 03/19/1998 |
| K970872 | GALLINI INTL., INC. | PAN (CHIBA ASPIRATING NEEDLE) | 05/21/1997 |
| K961407 | GALLINI INTL., INC. | SPEED-CUT | 11/21/1996 |
| K970871 | GALLINI INTL., INC. | TR NEEDLE | 05/21/1997 |
| K964777 | GALLINI INTL., INC. | TZ | 01/03/1997 |
| K980248 | GALLINI U.S., LLC. | ACRI R NEEDLE | 02/18/1998 |
| K973152 | GALLINI U.S., LLC. | GALLINI ABS DEVICE | 01/09/1998 |
| K990645 | GALLINI U.S., LLC. | GALLINI ATRA-CUT NEEDLE | 05/19/1999 |
| K992499 | GALLINI U.S., LLC. | GALLINI BIOSYSTEM BONE MARROW ASPIRATION/BIOPSY NEEDLE | 08/12/1999 |
| K990716 | GALLINI U.S., LLC. | GALLINI BYCUT NEEDLE | 05/17/1999 |
| K972266 | GALLINI U.S., LLC. | GALLINI COAXIAL INTRODUCER | 07/29/1997 |
| K974440 | GALLINI U.S., LLC. | IBI | 01/30/1998 |
| K980479 | GALLINI U.S., LLC. | QUICK-CUT AUTOMATIC BIOPSY SYSTEM | 05/06/1998 |
| K981301 | GALLINI U.S., LLC. | SPEED-CUT AUTOMATIC BIOPSY SYSTEM | 07/08/1998 |
| K980676 | GALLINI U.S., LLC. | SPIGAL NEEDLE | 05/21/1998 |
| K223300 | GEOTEK Medikal Ltd sti | Estacore-Pro Automatic Biopsy Needle, Geotek Semiautomatic Biopsy Needle, Maxicore-M Automatic Biopsy Gun Needle, Maxicore-M Automatic Biopsy Needle and Instrument | 04/21/2023 |
| K214063 | Guangzhou Shengwei Medical Devices Co., Ltd | Model 121 Biopsy Needle, Model 111 Biopsy Needle, Model 112 Biopsy Needle, and Model 131 Disposable Coaxial Biopsy Needle | 06/03/2022 |
| K033616 | H.S HOSPITAL SERVICE S.P.A. | TRAPMATIC SYSTEM SET | 03/01/2004 |
| K020987 | H.S. HOSPITAL SERVICE S.R.L. | BMN I TYPE MARROW ASPIRATION NEEDLE | 06/25/2002 |
| K013692 | H.S. HOSPITAL SERVICE S.R.L. | TRAPSYSTEM SET | 02/05/2002 |
| K013108 | HAKKO MEDICAL CO., LTD. | BIOSUC | 04/04/2002 |
| K180233 | Hologic, Inc | Eviva Stereotactic Guided Breast Biopsy System | 04/10/2018 |
| K150169 | Hologic, INC | Sertera Biopsy Device | 08/14/2015 |
| K163052 | HOLOGIC, INC. | Brevera Biopsy System with Corlumina Imaging Technology | 03/29/2017 |
| K993936 | IMAGYN SURGICAL | 15MM SITESELECT BREAST BIOPSY DEVICE, 10 MM SITESELECT BREAST BIOPSY DEVICE, 5MM SITESELECT BREAST BIOPSY DEVICE | 12/27/1999 |
| K011575 | IMAGYN SURGICAL | 22MM SITESELECT BREAST BIOPSY DEVICE MODEL SSD022 | 08/17/2001 |
| K981166 | INRAD | ACCUCORE CORE BIOPSY NEEDLE CATALOG CODES:581014, 581614, 581618, 582018, 582518, 581620, 582020, 581214 | 06/22/1998 |
| K000612 | INRAD | ACCUCORE SINGLE ACTION CORE BIOPSY DEVICE | 04/24/2000 |
| K981721 | INRAD | C0-AXIAL INTRODUCER NEEDLE | 07/28/1998 |
| K093399 | INRAD | PRECISECORE 10 MM BIOPSY DEVICE- 14GA X 5 CM MODEL 670514, 671014, 670518 671018, 670520 | 11/19/2009 |
| K090611 | INRAD | REVOLUTION FULL CORE BIOPSY | 06/04/2009 |
| K093256 | INRAD | SELECTCORE VARIABLE THROW BIOPSY DEVICE MODEL 991014, 991514, 991018, 991518, 992018 | 11/17/2009 |
| K112945 | INRAD INC. | ELITECORE FULL CORE BIOPSY DEVICE 18GAX10CM, 18GAX15CM, 18GAX20, WITH/HILITIER 18GAX10CM , W/HILITER 18GAX15CM | 11/03/2011 |
| K111529 | INSERT MOLDING SOLUTIONS, INC | MAGNUM CORE TISSUE BIOPSY NEEDLE MODEL MN1820, RP CUTTING NEEDLE MODEL RP-1820, MCN CORE TISSUE BIOPSY NEEDLE MODEL MCN- | 07/29/2011 |
| K142477 | INTACT MEDICAL CORPORATION | Intact Advance and Intact Excision XL, Intact BLES | 12/15/2014 |
| K060413 | INTACT MEDICAL CORPORATION | INTACT BREAST LESION EXCISION SYSTEM AND ADVANCE | 04/27/2006 |
| K081057 | INTACT MEDICAL CORPORATION | INTACT BREAST LESION EXCISION SYSTEM WITH INTACT EXCISION XL | 06/17/2008 |
| K152596 | INTACT MEDICAL CORPORATION | Intact« Gen2 System | 02/15/2016 |
| K990515 | INTERNATIONAL MEDICAL SYSTEMS | MATHIS VERTEBRAL AND BONE BIOPSY SYSTEM | 05/13/1999 |
| K963813 | INTERVENTIONAL CONCEPTS, INC. | SURE CORE BIOPSY KIT | 03/20/1997 |
| K222462 | ITP Innovative Tomography Products GmbH | Semi-automatic Biopsy-Needle (BIM 18/20); Semi-automatic Biopsy-Needle (BIM 18.15); Semi-automatic Biopsy-Needle (BIM 18/10);Semi-automatic Biopsy-Needle (BIM 16/20);Semi-automatic Biopsy-Needle (BIM 16/15);Semi-automatic Biopsy-Needle (BIM 16/10);Semi-au | 01/20/2023 |
| K152872 | K2M | K2M Fenestrated Tap System | 01/05/2016 |
| K230015 | Laurane Medical SAS | OmniBoneÖ Bone Marrow Biopsy Kit with Power Driver, OmniBoneÖ Bone Biopsy Kit with Power Driver | 06/16/2023 |
| K973215 | LAURUS MEDICAL CORP. | STEREOTACTIC NEEDLE CORE BIOPSY SYSTEM | 11/06/1997 |
| K954999 | LILY IMAGING SOLUTIONS CO. | LILY MULTICANNULA GUIDE | 04/04/1996 |
| K160316 | M.D.L. S.r.l. | SemiCut Semi-automatic Biopsy Needle, Themy Automatic Disposable Biopsy Device, Palium Automatic Reusable Biopsy Device, EasyCut Semi-automatic Biopsy Needle, MDL Biopsy and Coaxial Introducer Needles | 10/27/2016 |
| K974446 | MANAN MEDICAL PRODUCTS, INC. | MANAN AUTOMATIC CUTTING NEEDLE | 01/08/1998 |
| K052802 | MANAN MEDICAL PRODUCTS, INC. | MANAN BIO-CUT SOFT TISSUE BIOPSY NEEDLE | 11/01/2005 |
| K980211 | MANAN MEDICAL PRODUCTS, INC. | MRI CHIBA,SPINAL,BREAST LOCALIZATION,AUTOMATIC CUTTING NEEDLES | 02/06/1998 |
| K962977 | MANAN MEDICAL PRODUCTS, INC. | MRI COMPATIBLE BIOPSY NEEDLES | 10/09/1997 |
| K172344 | MEDAX S.R.L. UNIPERSONALE | Medax Biopsy Systems II (MEDONE, MEDCUT, MEDEM, MEDBONE, MEDLOCK) | 11/13/2017 |
| K192099 | Medax Srl Unipersonale | MED-I Bone Marrow Aspiration Needle, MED-S Bone Marrow Aspiration Needle, MED-L Bone Marrow Biopsy and Aspiration System, MED-B Bone Marrow Biopsy System, MED-J Bone Marrow Biopsy and Aspiration System | 04/02/2020 |
| K181803 | Medax Srl Unipersonale | Medax Biopsy Systems III | 10/18/2018 |
| K192101 | Medax Srl Unipersonale | Medone Ultra, Medextra | 04/02/2020 |
| K142125 | MEDAX SRL UNIPERSONALE | New Medax Biopsy Systems | 12/22/2015 |
| K092338 | MEDAX UNIPERSONALE SRL | MEDAX UNIPERSONALE SRL | 05/27/2011 |
| K981477 | MEDICAL BIOPSY, INC. | MEDICAL BIOPSY AUTOMATIC CUTTING NEEDLE | 06/10/1998 |
| K101832 | MEDICAL DEVICE TECHNOLOGIES, INC. | BIOPINCE ULTRA FULL CORE BIOPSY INSTRUMENT | 08/27/2010 |
| K043523 | MEDICAL DEVICE TECHNOLOGIES, INC. | INTERV BRAND SNARELOK BONE MARROW BIOPSY NEEDLE | 02/11/2005 |
| K980004 | MEDICAL DEVICE TECHNOLOGIES, INC. | MANAN GENERAL PURPOSE INTRODUCER NEEDLE | 01/09/1998 |
| K980452 | MEDICAL DEVICE TECHNOLOGIES, INC. | MANAN LIVER BIOPSY KIT | 02/18/1998 |
| K980226 | MEDICAL DEVICE TECHNOLOGIES, INC. | MANAN PRO-MAG AUTOMATIC BIOPSY SYSTEM | 02/18/1998 |
| K980122 | MEDICAL DEVICE TECHNOLOGIES, INC. | MANAN SOFT TISSUE BIOPSY NEEDLES | 01/30/1998 |
| K974766 | MEDICAL DEVICE TECHNOLOGIES, INC. | MANAN TECHNA-CUT ASPIRATION NEEDLE | 01/08/1998 |
| K974814 | MEDICAL DEVICE TECHNOLOGIES, INC. | MANAN(TM) SUPER-CORE BIOPSY NEEDLES | 01/09/1998 |
| K980196 | MEDICAL DEVICE TECHNOLOGIES, INC. | MD TECH BIOPSY SET FOR BONE AND BONE MARROW | 02/03/1998 |
| K982085 | MEDICAL DEVICE TECHNOLOGIES, INC. | MEDICAL DEVICE TECHNOLOGIES, INC. TRU-CORE DISPOSALE SEMI-AUTOMATIC BIOPDY INSTRUMENT | 07/17/1998 |
| K962969 | MEDICAL DEVICE TECHNOLOGIES, INC. | MEDICAL DEVICE TECHNOLOGIES, INC.ULTRA | 12/06/1996 |
| K982960 | MEDICAL DEVICE TECHNOLOGIES, INC. | MEICAL DEVICE TECHNOLOGIES, INC. TRU-CORE DISPOSABLE AUTOMATIC BIOPSY INSTRUMENT | 09/23/1998 |
| K990839 | MEDICAL DEVICE TECHNOLOGIES, INC. | TRU-CORE I REUSABLE BIOPSY INSTRUMENT | 05/20/1999 |
| K042464 | MEDICAL DEVICE TECHNOLOGIES, INC. | V-CORE FULL CORE BREAST BIOPSY INSTRUMENT | 09/30/2004 |
| K171890 | Medical Park CO., LTD | BEXCORE Breast Biopsy System, Biopsy Needle | 08/20/2018 |
| K060384 | MEDINVENTS | CORAMATE/SPIROTOME SYSTEM | 07/13/2006 |
| K080095 | MEDINVENTS | CORAMATE/SPIROTOME SYSTEM | 04/11/2008 |
| K983187 | MEDSOL CORP. | MEDSOL GOLDENBERG BONE MARROW BIOPSY NEEDLE | 12/10/1998 |
| K201166 | Merit Medical Systems, Inc | Temno Elite Biopsy System | 08/28/2020 |
| K180450 | Merit Medical Systems, Inc. | Corvocet Biopsy System | 03/12/2018 |
| K153337 | MERIT MEDICAL SYSTEMS, INC. | Corvocet Biopsy System | 03/25/2016 |
| K161409 | Mermaid Medical A/S | M-Biopsy Semi-Automatic Biopsy Instrument M-Biopsy Coaxial Introducer Needle for Sem | 08/02/2016 |
| K982735 | MINRAD, INC. | LIGHT SABER BONE BIOPSY NEEDLE | 09/09/1998 |
| K981796 | MINRAD, INC. | LIGHT SABER CORE TISSUE NEEDLE | 08/05/1998 |
| K071814 | MINRAD, INC. | LIGHT SABRE SPINAL ACCESS DEVICE | 10/16/2007 |
| K162588 | Moller Medical GmbH | M÷ller Medical Biopsy Needles and Systems | 06/19/2017 |
| K030443 | NASTECH PHARMACEUTICAL COMPANY, INC. | MAMMARY ASPIRATION SPECIMEN CYTOLOGY TEST | 05/09/2003 |
| K012088 | NASTECH PHARMACEUTICAL COMPANY, INC. | NASTECH MAMMARY ASPIRATION SPECIMAN CYTOLOGY TEST MASCT | 12/18/2001 |
| K220595 | NeoDynamics AB | NeoNavia Biopsy System | 09/08/2022 |
| K020848 | NEOMATRIX, LLC | NAFD 100 | 09/23/2002 |
| K033427 | NEOTHERMIA CORP. | MODIFICATION TO EN-BLOC BIOPSY SYSTEM | 11/10/2003 |
| K974158 | ORTHO DEVELOPMENT CORP. | ORION MEDICAL INC. DISPOSABLE BRAIN BIOPSY NEEDLE FOR STEROTACTIC GUIDED BIOPSY | 12/09/1997 |
| K050795 | ORTHOVITA, INC. | IMBIBE BONE MARROW ASPIRATION NEEDLE | 06/03/2005 |
| K153306 | ORTHOVITA, INC. | Imbibe Needle | 12/18/2015 |
| K113209 | PAJUNK GMBH | CHIBA SONO | 11/21/2011 |
| K063233 | PAJUNK GMBH MEDIZINTECHNOLOGIE | DELTACUT (APPARATUS AND CANNULA) | 04/30/2007 |
| K063697 | PAJUNK GMBH MEDIZINTECHNOLOGIE | SPECIAL SPROTTE, CHIBA, DR STEINHOFF KIT | 02/14/2007 |
| K022169 | PARALLAX MEDICAL, INC. | CLEARVIEW PLUS BONE AND VERTEBRAL BODY BIOPSY NEEDLES | 07/25/2002 |
| K011206 | PARALLAX MEDICAL, INC. | PARALLAX BONE AND VERTEBRAL BODY BIOPSY AND INFUSION NEEDLES | 07/18/2001 |
| K150088 | Pin-Point Care Corp. | Evacore Fully Disposable Vacuum Assist Biopsy Device | 07/20/2015 |
| K052435 | PNEUMRX, INC. | PNEUMRX FAMILY OF BIOPSY NEEDLES AND KITS | 11/03/2005 |
| K200278 | Praxis Medical, LLC | CytoCore | 03/31/2020 |
| K000135 | PRO.DUCT HEALTH, INC. | PRO.DUCT CATHETER, MODEL CTH03 | 04/10/2000 |
| K111765 | PROMEX TECHNOLOGIES, LLC | FULL CORE BIOPSY SYSTEM | 09/06/2011 |
| K994272 | PROMEX, INC. | AUTOMATED CORE BIOPSY DEVICE | 01/07/2000 |
| K001132 | PROMEX, INC. | BONE BIOPSY NEEDLE | 05/01/2000 |
| K993435 | PROMEX, INC. | MANUAL BONE MARROW BIOPSY DEVICE | 12/06/1999 |
| K010400 | PROMEX, INC. | VACUUM ASSISTED CORE BIOPSY DEVICE | 07/24/2001 |
| K210946 | Promisemed Hangzhou Meditech Co., Ltd. | Promisemed Automatic Biopsy Needles, Promisemed Co-Axial Biopsy Devices, Promisemed Semi-automatic Biopsy Needles | 08/12/2021 |
| K213683 | Promisemed Hangzhou Meditech Co., Ltd. | Promisemed Fine Biopsy Needle | 04/22/2022 |
| K150563 | RANFAC CORP | Marrow Cellution Bone Marrow Aspiration Needle | 05/22/2015 |
| K140991 | RANFAC CORP. | RANFAC ASPIRATION NEEDLE WITH ADJUSTABLE GUIDE | 09/11/2014 |
| K131157 | RANFAC CORP. | RANFAC BONE MARROW ASPIRATION NEEDLE | 10/22/2013 |
| K031344 | RANFAC CORP. | RANFAC GOLDENBERG SNARECOIL SOFT TISSUE BIOPSY (GSS) NEEDLE | 05/23/2003 |
| K012224 | RANFAC CORP. | SINGLE ACTION BIOPSY NEEDLE, MODEL RCBS: XX GAUGE, XX LENGTH, XX THROW | 08/22/2001 |
| K190177 | Ranfac Corporation | J-Type Marrow Biopsy Needle,T-Type Marrow Biopsy Needle,Tweezer Bone Marrow Biopsy Needle, | 06/12/2019 |
| K202287 | Ranfac Corporation | Ran-Flex-B Bone Marrow Aspiration Needle | 09/18/2020 |
| K183146 | Ranfac Corporation | Ranfac Cartilage Biopsy Needle | 04/25/2019 |
| K223612 | Ranfac Corporation | Ranfac Lateral Access Bone Marrow Aspiration Needle (CRVS-BMA-LA) | 02/21/2023 |
| K112468 | REGULATORY SPECIALISTS, INC. | THE ONCONTROL BONE ACCESS SYSTEM BY VIDACARE | 10/20/2011 |
| K040266 | REMINGTON MEDICAL, INC. | CORE NEEDLE BIOPSY | 07/09/2004 |
| K982401 | REMINGTON MEDICAL, INC. | PROSTATE BIOPSY NEEDLE | 09/08/1998 |
| K130282 | REMINGTON MEDICAL, INC. | REMINGTON MEDICAL CENTREFIRE 22 BIOPSY INSTRUMENT | 05/13/2013 |
| K191315 | Remington Medical, Inc. | Remington Medical, Inc. Automatic Cutting Needle (NAC) | 07/12/2019 |
| K092059 | RIVERPOINT MEDICAL | RP CUTTING NEEDLE | 09/24/2009 |
| K053151 | RUBICOR MEDICAL, INC. | RUBICOR MAGIC BREAST BIOPSY DEVICE | 11/18/2005 |
| K071048 | RUBICOR MEDICAL, INC. | RUBICOR MAGIC BREAST BIOPSY DEVICE, MODEL 31537 | 05/15/2007 |
| K022879 | SANARUS MEDICAL, INC. | MODIFICATION TO SANARUS CENTRICA CORE TISSUE BIOPSY | 09/23/2002 |
| K051581 | SANARUS MEDICAL, INC. | SANARUS CASSI II ROTATIONAL CORE BIOPSY SYSTEM, MODEL CS2000 | 07/27/2005 |
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