Endoscopic Tissue Approximation Device
FDA product code OCW · Class II (moderate risk) · 21 CFR 876.1500 · Gastroenterology, Urology
To aid in endoscopically placing sutures, staples, clips, and other fastening tools through tissue.
70510(k) clearances
0PMA approvals
4recalls
Manufacturers
- Ethicon Endo-Surgery, Inc. 11
- Apollo Endosurgery, Inc. 6
- Opus Medical, Inc. 4
- United States Surgical, A Division of Tyco Healthc 3
- Mini Lap Technologies, Inc. 3
- Barosense, Inc. 3
- Endogastric Solutions, Inc. 3
- Teleflexmedical, Inc. 2
- ETHICON, Inc. 2
- Arthrocare Corp. 2
- Covidien Lp, Formerly Registered AS United States 2
- Medeon Biodesign, Inc. 2
- Smith & Nephew Endoscopy, Inc. 2
- Covidien LLC 2
- Endo Tools Therapeutics S.A. 2
- Sutura, Inc. 1
- Envision Endoscopy 1
- Uromed Corp. 1
- Innovasive Devices, Inc. 1
- Origin Medsystems, Inc. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K252400 | Endomina EZFuse systemOCW · Traditional | Endo Tools Therapeutics S.A. | 02/13/2026SE |
| K243750 | SimpleStitch Suturing SystemOCW · Traditional | Envision Endoscopy | 04/17/2025SE |
| K231240 | MaxTack Motorized Fixation DeviceOCW · Traditional | Covidien | 09/08/2023SE |
| K213271 | MedicloseTM SystemOCW · Traditional | Health Value Creation B.V., Trading AS Corporis… | 08/31/2023SE |
| K231553 | OverStitch NXT Endoscopic Suturing SystemOCW · Special | Apollo Endosurgery, Inc. | 06/29/2023SE |
| K211309 | endomina systemOCW · Traditional | Endo Tools Therapeutics S.A. | 12/07/2021SE |
| K201744 | Su2ura Approximation DeviceOCW · Traditional | Anchora Medical, Ltd. | 06/17/2021SE |
| K210266 | OverStitch Sx Endoscopic Suturing SystemOCW · Special | Apollo Endosurgery, Inc. | 03/02/2021SE |
| K193652 | AbClose - Port Site Closure DeviceOCW · Traditional | Medeon Biodesign, Inc. | 03/26/2020SE |
| K191439 | OverStitch 2-0 Polypropylene SutureOCW · Traditional | Apollo Endosurgery | 08/29/2019SE |
| K181141 | OverStitch Endoscopic Suturing System and AccessoriesOCW · Special | Apollo Endosurgery | 06/27/2018SE |
| K172775 | MiniLap System with MiniGrip Handle, MiniLap System with ThumbGrip HandleOCW · Traditional | Teleflexmedical, Inc. | 02/12/2018SE |
| K172666 | CrossBow Fascial Closure System, CrossBow Fascial Closure System with AdaptorOCW · Traditional | Sutureease, Inc. | 12/01/2017SE |
| K171886 | OverStitch SX Endoscopic Suturing System (ESS)OCW · Traditional | Apollo Endosurgery, Inc. | 11/15/2017SE |
| K160117 | AbClose - Port Site Closure DeviceOCW · Traditional | Medeon Biodesign, Inc. | 09/09/2016SE |
| K160149 | Miret Grasper, Alligator, Miret Grasper, MarylandOCW · Traditional | Miret Surgical, Inc. | 08/30/2016SE |
| K132232 | Mins Needlescopic Resposable Device SystemOCW · Traditional | Minilap Technologies | 12/04/2013SE |
| K132362 | Weck Efx Endo Fascial Closure SystemOCW · Traditional | Teleflexmedical, Inc. | 10/08/2013SE |
| K120147 | Ace Stapler and CartridgeOCW · Special | Barosense, Inc. | 02/17/2012SE |
| K110829 | Ace Stapler and CartridgeOCW · Special | Barosense, Inc. | 06/03/2011SE |
| K103412 | Axiom Fascial Closure SystemOCW · Traditional | Axiom Technology Partners, LLC | 12/30/2010SE |
| K102931 | G-Cinch Suture GrasperOCW · Traditional | Usgi Medical | 12/30/2010SE |
| K101101 | Mini-TongOCW · Traditional | Mini Lap Technologies, Inc. | 07/23/2010SE |
| K082044 | Ace Stapler, Model F0031OCW · Traditional | Barosense, Inc. | 05/11/2010SE |
| K091832 | Endogastric Solutions Stomaphyx System with Serosafuse FastenerOCW · Special | Endogastric Solutions, Inc. | 07/22/2009SE |
| K090470 | Autosuture Protack; Tacker System; Absorbatack Fixation DevicesOCW · Traditional | Covidien | 05/14/2009SE |
| K090419 | Sils Stitch Endoscopic Suturing DeviceOCW · Special | Covidien Lp, Formerly Registered AS United States | 03/09/2009SE |
| K082659 | Modified Endo StichOCW · Special | Covidien Lp, Formerly Registered AS United States | 09/19/2008SE |
| K081853 | Overstitch Endoscopic Suture SystemOCW · Traditional | Apollo Endosurgery, Inc. | 08/18/2008SE |
| K073644 | Endogastric Solutions Stomaphyx Device and AccessoriesOCW · Traditional | Endogastric Solutions, Inc. | 06/27/2008SE |
| K073671 | Plicator GSX Suturing System, Plicator GSX, Plicator Instrument, Plicator GSX Suture…OCW · Traditional | Ndo Surgical, Inc. | 03/26/2008SE |
| K070151 | Inscope Tissue Anchors, Knotting Elements and Tissue Anchor and Knotting Element ApplierOCW · Traditional | Ethicon Endo-Surgery, LLC | 08/15/2007SE |
| K070671 | Opus Smartstitch Suture DeviceOCW · Special | Arthrocare Corp. | 04/06/2007SE |
| K070686 | Mini Lap InstrumentsOCW · Traditional | Mini Lap Technologies, Inc. | 04/05/2007SE |
| K070352 | Mini Lap Pediatric Instruments with Medusa Clamping SystemOCW · Traditional | Mini Lap Technologies, Inc. | 04/05/2007SE |
| K062875 | Endogastric Stomaphyx Device and AccessoriesOCW · Traditional | Endogastric Solutions, Inc. | 03/09/2007SE |
| K062244 | Opus Smartstich Suture Device with Perfectpasser ConnectorOCW · Special | Arthrocare Corp. | 10/02/2006SE |
| K061770 | Ethicon Endo Surgery Endoscopic Suturing SystemOCW · Traditional | Ethicon Endo-Surgery, Inc. | 09/25/2006SE |
| K033317 | Smartstitch M-Connector, Model OM-8700; Needle Cassette, OM-8750; Autocuff System…OCW · Traditional | Opus Medical, Inc. | 12/30/2003SE |
| K033269 | Endopath Endocutter Gray Cartridge, Model 6R45M/GRAY Cartridge ReloadOCW · Traditional | Ethicon Endo-Surgery, Inc. | 12/10/2003SE |
| K030170 | Reusable Smartstitch Suture Device, Models OM-8007, OM-8500OCW · Traditional | Opus Medical, Inc. | 07/28/2003SE |
| K023843 | Smartstitch M-Connector, Model OM-8005; Smartstitch Actuation Handle, Model OM-8500; and…OCW · Traditional | Opus Medical, Inc. | 02/14/2003SE |
| K022229 | Smartstitch Suture Device, Model OM-8500OCW · Traditional | Opus Medical, Inc. | 09/06/2002SE |
| K003949 | Tacker, Model R65-933OCW · Traditional | A & A Medical, Inc. | 07/25/2001SE |
| K003102 | Pare Endoscopic Suturing SystemOCW · Traditional | Pare Surgical, Inc. | 02/27/2001SE |
| K002398 | Endopath ETS45, Ets FLEX45, Ets COMPACT-FLEX45 Linear Cutters, Ets FLEX45 and Ets…OCW · Traditional | Ethicon Endo-Surgery, Inc. | 11/03/2000SE |
| K000717 | Smith & Nephew Suturelok, Model 7207321OCW · Special | Smith & Nephew, Inc. | 03/30/2000SE |
| K994087 | SuperstitchOCW · Traditional | Sutura, Inc. | 03/01/2000SE |
| K991500 | Smith & Nephew Suture LokOCW · Traditional | Smith & Nephew Endoscopy, Inc. | 07/14/1999SE |
| K980815 | Endopath EZ45 Endoscopic Linear CutterOCW · Traditional | Ethicon Endo-Surgery, Inc. | 05/01/1998SE |
| K974137 | Uromed Needle GrasperOCW · Traditional | Uromed Corp. | 01/30/1998SE |
| K973313 | Innovasive Devices Y-Knot Suture ClipOCW · Traditional | Innovasive Devices, Inc. | 12/01/1997SE |
| K971939 | Smith & Nephew Suture ColletOCW · Traditional | Smith & Nephew Endoscopy, Inc. | 08/06/1997SE |
| K970720 | Endopath EZ45 Endoscopic Linear Cutter and the Endopath EZ45 No Knife Endoscopic Linear…OCW · Traditional | Ethicon Endo-Surgery, Inc. | 06/27/1997SE |
| K963999 | Auto Suture* Modified Endoscopic Fascia Stapler** DeviceOCW · Traditional | United States Surgical, A Division of Tyco Healthc | 11/27/1996SE |
| K962493 | Endoscopic Clip ApplierOCW · Traditional | Aesculap, Inc. | 09/11/1996SE |
| K961390 | Endopath Ets Linear/Ets-Flex Articulating Linear Endoscopic CutterOCW · Traditional | Ethicon Endo-Surgery, Inc. | 06/25/1996SE |
| K960011 | Endoscopic Needle DriverOCW · Traditional | United States Surgical, A Division of Tyco Healthc | 02/21/1996SE |
| K954641 | Endo-LeaderOCW · Traditional | Microsurge, Inc. | 12/28/1995SE |
| K955479 | Koh Micro-Suturing InstrumentsOCW · Traditional | KARL STORZ Endoscopy-America, Inc. | 12/08/1995SE |
| K945202 | Endopath Endoscopic Reloadable Linear Cutter with Safety Loc-Out and Reloading UnitOCW · Traditional | Ethicon Endo-Surgery, Inc. | 01/19/1995SE |
| K944415 | Origin Tacker SystemOCW · Traditional | Origin Medsystems, Inc. | 11/28/1994SE |
| K944435 | Dosposable Enoscopic Hernia Surgical StaplerOCW · Traditional | Deroyal Industries, Inc. | 11/15/1994SE |
| K944292 | Surgical Innovations Disposable Endoscopic Hernia Surgical Stapler Surgical Innovations…OCW · Traditional | Surgical Innovations Corp. | 11/15/1994SE |
| K940967 | Modified Endopath IlsOCW · Traditional | Ethicon Endo-Surgery, Inc. | 05/27/1994SE |
| K935756 | Endoscopic Articulating Multi-Feed Stapler with Reload UnitOCW · Traditional | Ethicon Endo-Surgery, Inc. | 04/21/1994SE |
| K934738 | Autosuture Endoscopic Suturing DeviceOCW · Traditional | United States Surgical, A Division of Tyco Healthc | 03/16/1994SE |
| K934174 | Ligaclip Endoscopic Rotating Multiple Clip ApplierOCW · Traditional | ETHICON, Inc. | 03/09/1994SE |
| K932434 | Proximate Articulating Linear StaplerOCW · Traditional | Ethicon Endo-Surgery, Inc. | 02/07/1994SE |
| K935064 | Endopath Endoscopic Linear Cutter ModificationOCW · Traditional | ETHICON, Inc. | 01/03/1994SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-2962-2026 Class II | Suture Cinch Long 1pk. Endoscopic tissue approximation device.Device may fail to deploy the cinch implant and/or fail to cut the suture as intended. | Boston Scientific Corporation | 07/14/2026Open, Classified |
| Z-2961-2026 Class II | OverStitch Suture Cinch, 1pk. Endoscopic tissue approximation device.Device may fail to deploy the cinch implant and/or fail to cut the suture as intended. | Boston Scientific Corporation | 07/14/2026Open, Classified |
| Z-2281-2026 Class II | Covidien EndoStitch" Polysorb Single Use Loading Unit; Product numbers: 170053 and 170071;The presence of holes in the pouch may compromise the package s ability to maintain the sterile barrier and… | Covidien, LP | 04/15/2026Open, Classified |
| Z-0986-2024 Class II | AbsorbaTack Absorbable Fixation Device 30 Violet Absorbable Tacks 5 mm- -intended for…Packaging of the device may cause a low seal strength in the side seal of the foil pouch potentially… | Covidien LP | 11/16/2023Open, Classified |