Clearance Summary
colonic FTRD Set (200.70); diagnostic FTRD Set (200.76); gastroduodenal FTRD Set (200.72) received FDA 510(k) clearance under submission number K253481, sponsored by Ovesco Endoscopy AG. The device was reviewed via the Traditional premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 2026-09-14.
- Submission: K253481
- Applicant / Sponsor: Ovesco Endoscopy AG
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.4400
- Decision date: 2026-09-14
Classification & Regulation
This clearance is catalogued under FDA product code PKL and 21 CFR 876.4400, within the Gastroenterology, Urology review panel as a Class II device.