Product code OCW
- Device name
- Endoscopic Tissue Approximation Device
- Medical specialty
- Gastroenterology, Urology
- Device class
- 2
- Regulation number
- 876.1500
- Review panel
- GU
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Definition
- To aid in endoscopically placing sutures, staples, clips, and other fastening tools through tissue.
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K252400 | Endomina EZFuse system | Endo Tools Therapeutics S.A. | 2026-02-13 |
| K243750 | SimpleStitch Suturing System | Envision Endoscopy | 2025-04-17 |
| K231240 | MaxTack™ Motorized Fixation Device | Covidien | 2023-09-08 |
| K213271 | MedicloseTM System | Health Value Creation B.V., Trading AS Corporis Medical | 2023-08-31 |
| K231553 | OverStitch NXT Endoscopic Suturing System | Apollo Endosurgery, Inc. | 2023-06-29 |
| K211309 | endomina system | Endo Tools Therapeutics S.A. | 2021-12-07 |
| K201744 | Su2ura Approximation Device | Anchora Medical, Ltd. | 2021-06-17 |
| K210266 | OverStitch Sx Endoscopic Suturing System | Apollo Endosurgery, Inc. | 2021-03-02 |
| K193652 | AbClose - Port Site Closure Device | Medeon Biodesign, Inc. | 2020-03-26 |
| K191439 | OverStitch 2-0 Polypropylene Suture | Apollo Endosurgery | 2019-08-29 |
| K181141 | OverStitch Endoscopic Suturing System and Accessories | Apollo Endosurgery | 2018-06-27 |
| K172775 | MiniLap System with MiniGrip Handle, MiniLap System with ThumbGrip Handle | Teleflexmedical, Inc. | 2018-02-12 |
| K172666 | CrossBow Fascial Closure System, CrossBow Fascial Closure System with Adaptor | Sutureease, Inc. | 2017-12-01 |
| K171886 | OverStitch SX Endoscopic Suturing System (ESS) | Apollo Endosurgery, Inc. | 2017-11-15 |
| K160117 | AbClose - Port Site Closure Device | Medeon Biodesign, Inc. | 2016-09-09 |
| K160149 | Miret Grasper, Alligator, Miret Grasper, Maryland | Miret Surgical, Inc. | 2016-08-30 |
| K132232 | MINS NEEDLESCOPIC RESPOSABLE DEVICE SYSTEM | Minilap Technologies | 2013-12-04 |
| K132362 | WECK EFX ENDO FASCIAL CLOSURE SYSTEM | Teleflexmedical, Inc. | 2013-10-08 |
| K120147 | ACE STAPLER AND CARTRIDGE | Barosense, Inc. | 2012-02-17 |
| K110829 | ACE STAPLER AND CARTRIDGE | Barosense, Inc. | 2011-06-03 |
| K103412 | AXIOM FASCIAL CLOSURE SYSTEM | Axiom Technology Partners, LLC | 2010-12-30 |
| K102931 | G-CINCH SUTURE GRASPER | Usgi Medical | 2010-12-30 |
| K101101 | MINI-TONG | Mini Lap Technologies, Inc. | 2010-07-23 |
| K082044 | ACE STAPLER, MODEL F0031 | Barosense, Inc. | 2010-05-11 |
| K091832 | ENDOGASTRIC SOLUTIONS STOMAPHYX SYSTEM WITH SEROSAFUSE FASTENER | Endogastric Solutions, Inc. | 2009-07-22 |
| K090470 | AUTOSUTURE PROTACK; TACKER SYSTEM; ABSORBATACK FIXATION DEVICES | Covidien | 2009-05-14 |
| K090419 | SILS STITCH ENDOSCOPIC SUTURING DEVICE | Covidien Lp, Formerly Registered AS United States | 2009-03-09 |
| K082659 | MODIFIED ENDO STICH | Covidien Lp, Formerly Registered AS United States | 2008-09-19 |
| K081853 | OVERSTITCH ENDOSCOPIC SUTURE SYSTEM | Apollo Endosurgery, Inc. | 2008-08-18 |
| K073644 | ENDOGASTRIC SOLUTIONS STOMAPHYX DEVICE AND ACCESSORIES | Endogastric Solutions, Inc. | 2008-06-27 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 10884521826267 | MaxTack | Covidien LP | 2024-09-09 |
| 10811955020770 | X-Tack Endoscopic HeliX Tacking System | Apollo Endosurgery, Inc. | 2021-07-12 |
| 10811955020763 | X-Tack Endoscopic HeliX Tacking System | Apollo Endosurgery, Inc. | 2021-07-12 |
| 10811955020756 | X-Tack Endoscopic HeliX Tacking System | Apollo Endosurgery, Inc. | 2021-07-12 |
| 10811955020718 | OverStitch Endoscopic Suturing System Sx | Apollo Endosurgery, Inc. | 2021-05-26 |
| 10652927256212 | DemeLENE | Demetech Corporation | 2017-11-28 |
| 10811955020688 | OverStitch Endoscopic Suturing System | Apollo Endosurgery, Inc. | 2016-10-07 |
| 20884521126852 | Sofsilk | Covidien LP | 2016-09-24 |
| 10884521129443 | Surgidac | Covidien LP | 2016-09-24 |
| 10884521129436 | Surgidac | Covidien LP | 2016-09-24 |
| 10884521126893 | Sofsilk | Covidien LP | 2016-09-24 |
| 10884521100022 | SILS Stitch | Covidien LP | 2016-09-24 |
| 10884521100015 | Endo Stitch | Covidien LP | 2016-09-24 |
| 10884521100008 | Endo Stitch | Covidien LP | 2016-09-24 |
| 10884521129450 | Surgidac | Covidien LP | 2016-09-24 |
| 10884521129467 | Surgidac | Covidien LP | 2016-09-24 |
| 10884521070400 | ProTack | Covidien LP | 2016-09-24 |
| 10811955020664 | OverStitch Endoscopic Suturing System | Apollo Endosurgery, Inc. | 2016-08-19 |
| 10811955020671 | OverStitch Endoscopic Suturing System | Apollo Endosurgery, Inc. | 2016-08-19 |
| 10705036003489 | N/A | ETHICON ENDO-SURGERY, LLC | 2016-07-15 |
| 10705036003496 | N/A | ETHICON ENDO-SURGERY, LLC | 2016-07-15 |
| 10705036003502 | N/A | ETHICON ENDO-SURGERY, LLC | 2016-07-15 |
| 10705036012412 | N/A | ETHICON ENDO-SURGERY, LLC | 2016-07-15 |
| 10884521070486 | Tacker | Covidien LP | 2015-09-02 |
| 10884521070509 | Stat Tack | Covidien LP | 2015-09-02 |
| 10884521070493 | Tacker | Covidien LP | 2015-09-02 |
| 10884521070455 | Tacker | Covidien LP | 2015-09-02 |
| 10884523006155 | AbsorbaTack | Covidien LP | 2015-08-31 |
| 10884523006506 | AbsorbaTack | Covidien LP | 2015-08-31 |
| 10884523006520 | AbsorbaTack | Covidien LP | 2015-08-31 |