OCW
- Product code
- OCW
- Device name
- Endoscopic Tissue Approximation Device
- Device class
- Class 2
- 21 CFR
- 21 CFR 876.1500
- Medical specialty
- Gastroenterology, Urology
- Marketing pathway
- 510(K)
- 510(k) clearances (last 3 years)
- 2
- Summaries archived here
- 2 (direct download)
- 510(k) clearances (all years, FDA)
- 70 (all years; only the last 3 years are listed here)
FDA classification definition
To aid in endoscopically placing sutures, staples, clips, and other fastening tools through tissue.
510(k) clearances, last 3 years (2)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K252400 | 2026-02-13 | Endo Tools Therapeutics S.A. | Endomina EZFuse system | |
| K243750 | 2025-04-17 | Envision Endoscopy | SimpleStitch Suturing System |
Official FDA classification page: OCW
Classification and pathway per current FDA publications. Data from openFDA (CC0).