OCW — Endoscopic Tissue Approximation Device Class II
FDA product code OCW covers "Endoscopic Tissue Approximation Device", a Class II medical device regulated under 21 CFR 876.1500. Submissions are reviewed by the Gastroenterology, Urology panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- OCW
- Device Class
- Class II
- Regulation Number
- 876.1500
- Submission Type
- Review Panel
- GU
- Medical Specialty
- Gastroenterology, Urology
- Implant
- No
Definition
To aid in endoscopically placing sutures, staples, clips, and other fastening tools through tissue.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K252400 | endo tools therapeutics | Endomina EZFuse system | February 13, 2026 |
| K243750 | envision endoscopy | SimpleStitch Suturing System | April 17, 2025 |
| K231240 | covidien | MaxTack Motorized Fixation Device | September 8, 2023 |
| K213271 | health value creation b.v., trading as corporis medical | MedicloseTM System | August 31, 2023 |
| K231553 | apollo endosurgery | OverStitch NXT Endoscopic Suturing System | June 29, 2023 |
| K211309 | endo tools therapeutics | endomina system | December 7, 2021 |
| K201744 | anchora medical | Su2ura Approximation Device | June 17, 2021 |
| K210266 | apollo endosurgery | OverStitch Sx Endoscopic Suturing System | March 2, 2021 |
| K193652 | medeon biodesign | AbClose - Port Site Closure Device | March 26, 2020 |
| K191439 | apollo endosurgery | OverStitch 2-0 Polypropylene Suture | August 29, 2019 |
| K181141 | apollo endosurgery | OverStitch Endoscopic Suturing System and Accessories | June 27, 2018 |
| K172775 | teleflexmedical | MiniLap System with MiniGrip Handle, MiniLap System with ThumbGrip Handle | February 12, 2018 |
| K172666 | sutureease | CrossBow Fascial Closure System, CrossBow Fascial Closure System with Adaptor | December 1, 2017 |
| K171886 | apollo endosurgery | OverStitch SX Endoscopic Suturing System (ESS) | November 15, 2017 |
| K160117 | medeon biodesign | AbClose - Port Site Closure Device | September 9, 2016 |
| K160149 | miret surgical | Miret Grasper, Alligator, Miret Grasper, Maryland | August 30, 2016 |
| K132232 | minilap technologies | MINS NEEDLESCOPIC RESPOSABLE DEVICE SYSTEM | December 4, 2013 |
| K132362 | teleflexmedical | WECK EFX ENDO FASCIAL CLOSURE SYSTEM | October 8, 2013 |
| K120147 | barosense | ACE STAPLER AND CARTRIDGE | February 17, 2012 |
| K110829 | barosense | ACE STAPLER AND CARTRIDGE | June 3, 2011 |