510(k) clearance
colonic FTRD Set (200.70); diagnostic FTRD Set (200.76); gastroduodenal FTRD Set (200.72)
- 510(k) number
- K253481
- Applicant
- Ovesco Endoscopy AG
- Decision date
- Sep 14, 2026
- Date received
- Oct 14, 2025
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Product code
- PKL
- Device type
- Hemostatic Metal Clip For The Gi Tract
- Device class
- Class II
- Regulation
- 21 CFR 876.4400
- Advisory committee
- Gastroenterology, Urology
- Statement or summary
- Summary
- Third party
- N
- Location
- Tuebingen, DE