FDA 510(k) Applications for Medical Device Product Code "OCW"
(Endoscopic Tissue Approximation Device)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K003949 | A & A MEDICAL, INC. | TACKER, MODEL R65-933 | 07/25/2001 |
| K962493 | AESCULAP, INC. | ENDOSCOPIC CLIP APPLIER | 09/11/1996 |
| K201744 | Anchora Medical, Ltd. | Su2ura Approximation Device | 06/17/2021 |
| K191439 | Apollo Endosurgery | OverStitch 2-0 Polypropylene Suture | 08/29/2019 |
| K181141 | Apollo Endosurgery | OverStitch Endoscopic Suturing System and Accessories | 06/27/2018 |
| K171886 | Apollo Endosurgery Inc | OverStitch SX Endoscopic Suturing System (ESS) | 11/15/2017 |
| K231553 | Apollo Endosurgery Inc. | OverStitch NXT Endoscopic Suturing System | 06/29/2023 |
| K210266 | Apollo Endosurgery Inc. | OverStitch Sx Endoscopic Suturing System | 03/02/2021 |
| K081853 | APOLLO ENDOSURGERY, INC. | OVERSTITCH ENDOSCOPIC SUTURE SYSTEM | 08/18/2008 |
| K062244 | ARTHROCARE CORP. | OPUS SMARTSTICH SUTURE DEVICE WITH PERFECTPASSER CONNECTOR | 10/02/2006 |
| K070671 | ARTHROCARE CORP. | OPUS SMARTSTITCH SUTURE DEVICE | 04/06/2007 |
| K103412 | AXIOM TECHNOLOGY PARTNERS, LLC | AXIOM FASCIAL CLOSURE SYSTEM | 12/30/2010 |
| K110829 | BAROSENSE, INC | ACE STAPLER AND CARTRIDGE | 06/03/2011 |
| K120147 | BAROSENSE, INC | ACE STAPLER AND CARTRIDGE | 02/17/2012 |
| K082044 | BAROSENSE, INC | ACE STAPLER, MODEL F0031 | 05/11/2010 |
| K090470 | COVIDIEN | AUTOSUTURE PROTACK; TACKER SYSTEM; ABSORBATACK FIXATION DEVICES | 05/14/2009 |
| K082659 | COVIDIEN LP, FORMERLY REGISTERED AS UNITED STATES | MODIFIED ENDO STICH | 09/19/2008 |
| K090419 | COVIDIEN LP, FORMERLY REGISTERED AS UNITED STATES | SILS STITCH ENDOSCOPIC SUTURING DEVICE | 03/09/2009 |
| K211309 | Endo Tools Therapeutics S.A. | endomina system | 12/07/2021 |
| K073644 | ENDOGASTRIC SOLUTIONS, INC. | ENDOGASTRIC SOLUTIONS STOMAPHYX DEVICE AND ACCESSORIES | 06/27/2008 |
| K091832 | ENDOGASTRIC SOLUTIONS, INC. | ENDOGASTRIC SOLUTIONS STOMAPHYX SYSTEM WITH SEROSAFUSE FASTENER | 07/22/2009 |
| K062875 | ENDOGASTRIC SOLUTIONS, INC. | ENDOGASTRIC STOMAPHYX DEVICE AND ACCESSORIES | 03/09/2007 |
| K033269 | ETHICON ENDO-SURGERY, INC. | ENDOPATH ENDOCUTTER GRAY CARTRIDGE, MODEL 6R45M/GRAY CARTRIDGE RELOAD | 12/10/2003 |
| K961390 | ETHICON ENDO-SURGERY, INC. | ENDOPATH ETS LINEAR/ETS-FLEX ARTICULATING LINEAR ENDOSCOPIC CUTTER | 06/25/1996 |
| K002398 | ETHICON ENDO-SURGERY, INC. | ENDOPATH ETS45, ETS FLEX45, ETS COMPACT-FLEX45 LINEAR CUTTERS, ETS FLEX45 AND ETS COMPACT-FLEX45 NO-KNIFE ARTICULATING | 11/03/2000 |
| K980815 | ETHICON ENDO-SURGERY, INC. | ENDOPATH EZ45 ENDOSCOPIC LINEAR CUTTER | 05/01/1998 |
| K970720 | ETHICON ENDO-SURGERY, INC. | ENDOPATH EZ45 ENDOSCOPIC LINEAR CUTTER AND THE ENDOPATH EZ45 NO KNIFE ENDOSCOPIC LINEAR STAPLER | 06/27/1997 |
| K061770 | ETHICON ENDO-SURGERY, INC. | ETHICON ENDO SURGERY ENDOSCOPIC SUTURING SYSTEM | 09/25/2006 |
| K070151 | ETHICON ENDO-SURGERY, LLC | INSCOPE TISSUE ANCHORS, KNOTTING ELEMENTS AND TISSUE ANCHOR AND KNOTTING ELEMENT APPLIER | 08/15/2007 |
| K213271 | Health Value Creation BV, trading as Corporis Medical | MedicloseTM System | 08/31/2023 |
| K973313 | INNOVASIVE DEVICES, INC. | INNOVASIVE DEVICES Y-KNOT SUTURE CLIP | 12/01/1997 |
| K160117 | Medeon Biodesign, Inc | AbClose - Port Site Closure Device | 09/09/2016 |
| K193652 | Medeon Biodesign, Inc. | AbClose - Port Site Closure Device | 03/26/2020 |
| K070686 | MINI LAP TECHNOLOGIES INC. | MINI LAP INSTRUMENTS | 04/05/2007 |
| K070352 | MINI LAP TECHNOLOGIES INC. | MINI LAP PEDIATRIC INSTRUMENTS WITH MEDUSA CLAMPING SYSTEM | 04/05/2007 |
| K101101 | MINI LAP TECHNOLOGIES INC. | MINI-TONG | 07/23/2010 |
| K132232 | MINILAP TECHNOLOGIES | MINS NEEDLESCOPIC RESPOSABLE DEVICE SYSTEM | 12/04/2013 |
| K160149 | MIRET SURGICAL INC. | Miret Grasper, Alligator, Miret Grasper, Maryland | 08/30/2016 |
| K073671 | NDO SURGICAL, INC. | PLICATOR GSX SUTURING SYSTEM, PLICATOR GSX, PLICATOR INSTRUMENT, PLICATOR GSX SUTURE CARTRIDGE | 03/26/2008 |
| K030170 | OPUS MEDICAL, INC. | REUSABLE SMARTSTITCH SUTURE DEVICE, MODELS OM-8007, OM-8500 | 07/28/2003 |
| K023843 | OPUS MEDICAL, INC. | SMARTSTITCH M-CONNECTOR, MODEL OM-8005; SMARTSTITCH ACTUATION HANDLE, MODEL OM-8500; AND SMARTSTITCH SUTURE CARTRIDGE | 02/14/2003 |
| K033317 | OPUS MEDICAL, INC. | SMARTSTITCH M-CONNECTOR, MODEL OM-8700; NEEDLE CASSETTE, OM-8750; AUTOCUFF SYSTEM INSTRUMENT SET, OM-9070 | 12/30/2003 |
| K022229 | OPUS MEDICAL, INC. | SMARTSTITCH SUTURE DEVICE, MODEL OM-8500 | 09/06/2002 |
| K003102 | PARE SURGICAL, INC. | PARE ENDOSCOPIC SUTURING SYSTEM | 02/27/2001 |
| K971939 | SMITH & NEPHEW ENDOSCOPY, INC. | SMITH & NEPHEW SUTURE COLLET | 08/06/1997 |
| K991500 | SMITH & NEPHEW ENDOSCOPY, INC. | SMITH & NEPHEW SUTURE LOK | 07/14/1999 |
| K000717 | SMITH & NEPHEW, INC. | SMITH & NEPHEW SUTURELOK, MODEL 7207321 | 03/30/2000 |
| K994087 | SUTURA, INC. | SUPERSTITCH | 03/01/2000 |
| K172666 | SutureEase, Inc. | CrossBow Fascial Closure System, CrossBow Fascial Closure System with Adaptor | 12/01/2017 |
| K172775 | Teleflex Medical, Inc. | MiniLap System with MiniGrip Handle, MiniLap System with ThumbGrip Handle | 02/12/2018 |
| K132362 | Teleflex Medical, Inc. | WECK EFX ENDO FASCIAL CLOSURE SYSTEM | 10/08/2013 |
| K963999 | UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC | AUTO SUTURE* MODIFIED ENDOSCOPIC FASCIA STAPLER** DEVICE | 11/27/1996 |
| K960011 | UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC | ENDOSCOPIC NEEDLE DRIVER | 02/21/1996 |
| K974137 | UROMED CORP. | UROMED NEEDLE GRASPER | 01/30/1998 |
| K102931 | USGI MEDICAL | G-CINCH SUTURE GRASPER | 12/30/2010 |
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