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The Tracker / September 2026 / K253481

510(k) cleared

colonic FTRD Set (200.70); diagnostic FTRD Set (200.76); gastroduodenal FTRD Set (200.72)

Ovesco Endoscopy AG · Sep 14, 2026 · K253481

FDA cleared the colonic FTRD Set (200.70); diagnostic FTRD Set (200.76); gastroduodenal FTRD Set (200.72) from Ovesco Endoscopy AG on Sep 14, 2026 under K253481, a traditional 510(k). The device falls under product code PKL, Hemostatic Metal Clip For The Gi Tract, regulated at 21 CFR 876.4400 as a Class 2 device. The review panel was Gastroenterology, Urology.

FDA logged the submission as received on Oct 14, 2025. The decision came 335 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Ovesco Endoscopy AG has one other decision in the tracker over the last 12 months: K251562 (OTSCneo System Set (100.03n-14n, 100.27n-31n)).

Questions & Answers

What did FDA clear under K253481?

K253481 is the FDA 510(k) for colonic FTRD Set (200.70); diagnostic FTRD Set (200.76); gastroduodenal FTRD Set (200.72), submitted by Ovesco Endoscopy AG. FDA's decision date was Sep 14, 2026, under product code PKL (Hemostatic Metal Clip For The Gi Tract).

Who makes the colonic FTRD Set (200.70); diagnostic FTRD Set (200.76); gastroduodenal FTRD Set (200.72)?

Ovesco Endoscopy AG, based in Tuebingen, is the applicant of record for K253481.

How long did the K253481 review take?

FDA received the submission on Oct 14, 2025 and issued its decision on Sep 14, 2026, 335 days later.

← All decisions in September 2026

Sources