Panels › Gastroenterology, Urology › Product code OCW · Class 2
Endoscopic Tissue Approximation Device
Regulation 876.1500
2510(k)s in 12 months (71 all time)
3recalls in 12 months (4 all time)
4recalls that name a 510(k)
Top companies in OCW
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 14, 2026 | K262044 | Mediclose Cartridge System Health Value Creation B.V. (trading as Corporis Medical), NL | OCW |
| Feb 13, 2026 | K252400 | Endomina EZFuse system Endo Tools Therapeutics S.A., BE | OCW |
| Apr 17, 2025 | K243750 | SimpleStitch Suturing System Envision Endoscopy | OCW |
| Sep 8, 2023 | K231240 | MaxTack Motorized Fixation Device Covidien | OCW |
| Aug 31, 2023 | K213271 | MedicloseTM System Health Value Creation B.V., Trading AS Corporis Medical, NL | OCW |
| Jun 29, 2023 | K231553 | OverStitch NXT Endoscopic Suturing System Apollo Endosurgery, Inc. | OCW |
| Dec 7, 2021 | K211309 | endomina system Endo Tools Therapeutics S.A., BE | OCW |
| Jun 17, 2021 | K201744 | Su2ura Approximation Device Anchora Medical, Ltd., IL | OCW |
| Mar 2, 2021 | K210266 | OverStitch Sx Endoscopic Suturing System Apollo Endosurgery, Inc. | OCW |
| Mar 26, 2020 | K193652 | AbClose - Port Site Closure Device Medeon Biodesign, Inc., TW | OCW |
| Aug 29, 2019 | K191439 | OverStitch 2-0 Polypropylene Suture Apollo Endosurgery | OCW |
| Jun 27, 2018 | K181141 | OverStitch Endoscopic Suturing System and Accessories Apollo Endosurgery | OCW |
| Feb 12, 2018 | K172775 | MiniLap System with MiniGrip Handle, MiniLap System with ThumbGrip Handle Teleflexmedical, Inc. | OCW |
| Dec 1, 2017 | K172666 | CrossBow Fascial Closure System, CrossBow Fascial Closure System with Adaptor Sutureease, Inc. | OCW |
| Nov 15, 2017 | K171886 | OverStitch SX Endoscopic Suturing System (ESS) Apollo Endosurgery, Inc. | OCW |
| Sep 9, 2016 | K160117 | AbClose - Port Site Closure Device Medeon Biodesign, Inc., TW | OCW |
| Aug 30, 2016 | K160149 | Miret Grasper, Alligator, Miret Grasper, Maryland Miret Surgical, Inc. | OCW |
| Dec 4, 2013 | K132232 | MINS NEEDLESCOPIC RESPOSABLE DEVICE SYSTEM Minilap Technologies | OCW |
| Oct 8, 2013 | K132362 | WECK EFX ENDO FASCIAL CLOSURE SYSTEM Teleflexmedical, Inc. | OCW |
| Feb 17, 2012 | K120147 | ACE STAPLER AND CARTRIDGE Barosense, Inc. | OCW |
| Jun 3, 2011 | K110829 | ACE STAPLER AND CARTRIDGE Barosense, Inc. | OCW |
| Dec 30, 2010 | K103412 | AXIOM FASCIAL CLOSURE SYSTEM Axiom Technology Partners, LLC | OCW |
| Dec 30, 2010 | K102931 | G-CINCH SUTURE GRASPER Usgi Medical | OCW |
| Jul 23, 2010 | K101101 | MINI-TONG Mini Lap Technologies, Inc. | OCW |
| May 11, 2010 | K082044 | ACE STAPLER, MODEL F0031 Barosense, Inc. | OCW |
| Jul 22, 2009 | K091832 | ENDOGASTRIC SOLUTIONS STOMAPHYX SYSTEM WITH SEROSAFUSE FASTENER Endogastric Solutions, Inc. | OCW |
| May 14, 2009 | K090470 | AUTOSUTURE PROTACK; TACKER SYSTEM; ABSORBATACK FIXATION DEVICES Covidien | OCW |
| Mar 9, 2009 | K090419 | SILS STITCH ENDOSCOPIC SUTURING DEVICE Covidien Lp, Formerly Registered AS United States | OCW |
| Sep 19, 2008 | K082659 | MODIFIED ENDO STICH Covidien Lp, Formerly Registered AS United States | OCW |
| Aug 18, 2008 | K081853 | OVERSTITCH ENDOSCOPIC SUTURE SYSTEM Apollo Endosurgery, Inc. | OCW |
| Jun 27, 2008 | K073644 | ENDOGASTRIC SOLUTIONS STOMAPHYX DEVICE AND ACCESSORIES Endogastric Solutions, Inc. | OCW |
| Mar 26, 2008 | K073671 | PLICATOR GSX SUTURING SYSTEM, PLICATOR GSX, PLICATOR INSTRUMENT, PLICATOR GSX SUTURE CARTRIDGE Ndo Surgical, Inc. | OCW |
| Aug 15, 2007 | K070151 | INSCOPE TISSUE ANCHORS, KNOTTING ELEMENTS AND TISSUE ANCHOR AND KNOTTING ELEMENT APPLIER Ethicon Endo-Surgery, LLC | OCW |
| Apr 6, 2007 | K070671 | OPUS SMARTSTITCH SUTURE DEVICE Arthrocare Corp. | OCW |
| Apr 5, 2007 | K070686 | MINI LAP INSTRUMENTS Mini Lap Technologies, Inc. | OCW |
| Apr 5, 2007 | K070352 | MINI LAP PEDIATRIC INSTRUMENTS WITH MEDUSA CLAMPING SYSTEM Mini Lap Technologies, Inc. | OCW |
| Mar 9, 2007 | K062875 | ENDOGASTRIC STOMAPHYX DEVICE AND ACCESSORIES Endogastric Solutions, Inc. | OCW |
| Oct 2, 2006 | K062244 | OPUS SMARTSTICH SUTURE DEVICE WITH PERFECTPASSER CONNECTOR Arthrocare Corp. | OCW |
| Sep 25, 2006 | K061770 | ETHICON ENDO SURGERY ENDOSCOPIC SUTURING SYSTEM Ethicon Endo-Surgery, Inc. | OCW |
| Dec 30, 2003 | K033317 | SMARTSTITCH M-CONNECTOR, MODEL OM-8700; NEEDLE CASSETTE, OM-8750; AUTOCUFF SYSTEM INSTRUMENT SET, OM-9070 Opus Medical, Inc. | OCW |
| Dec 10, 2003 | K033269 | ENDOPATH ENDOCUTTER GRAY CARTRIDGE, MODEL 6R45M/GRAY CARTRIDGE RELOAD Ethicon Endo-Surgery, Inc. | OCW |
| Jul 28, 2003 | K030170 | REUSABLE SMARTSTITCH SUTURE DEVICE, MODELS OM-8007, OM-8500 Opus Medical, Inc. | OCW |
| Feb 14, 2003 | K023843 | SMARTSTITCH M-CONNECTOR, MODEL OM-8005; SMARTSTITCH ACTUATION HANDLE, MODEL OM-8500; AND SMARTSTITCH SUTURE CARTRIDGE Opus Medical, Inc. | OCW |
| Sep 6, 2002 | K022229 | SMARTSTITCH SUTURE DEVICE, MODEL OM-8500 Opus Medical, Inc. | OCW |
| Jul 25, 2001 | K003949 | TACKER, MODEL R65-933 A & A Medical, Inc. | OCW |
| Feb 27, 2001 | K003102 | PARE ENDOSCOPIC SUTURING SYSTEM Pare Surgical, Inc. | OCW |
| Nov 3, 2000 | K002398 | ENDOPATH ETS45, ETS FLEX45, ETS COMPACT-FLEX45 LINEAR CUTTERS, ETS FLEX45 AND ETS COMPACT-FLEX45 NO-KNIFE ARTICULATING Ethicon Endo-Surgery, Inc. | OCW |
| Mar 30, 2000 | K000717 | SMITH & NEPHEW SUTURELOK, MODEL 7207321 Smith & Nephew, Inc. | OCW |
| Mar 1, 2000 | K994087 | SUPERSTITCH Sutura, Inc. | OCW |
| Jul 14, 1999 | K991500 | SMITH & NEPHEW SUTURE LOK Smith & Nephew Endoscopy, Inc. | OCW |
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