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FDA 510(k)

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

K-Number: K253481 · 2026-09-14

ApplicantOvesco Endoscopy AG
Decision Date2026-09-14
Product CodePKL
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

colonic FTRD Set (200.70); diagnostic FTRD Set (200.76); gastroduodenal FTRD Set (200.72) is the device name listed in this FDA 510(k) record. The listed applicant is Ovesco Endoscopy AG. It received FDA 510(k) clearance on 2026-09-14 under 510(k) number K253481. The device is classified under product code PKL. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the colonic FTRD Set (200.70); diagnostic FTRD Set (200.76); gastroduodenal FTRD Set (200.72)?

colonic FTRD Set (200.70); diagnostic FTRD Set (200.76); gastroduodenal FTRD Set (200.72) is a medical device that received FDA 510(k) clearance on 2026-09-14. The listed applicant is Ovesco Endoscopy AG. The 510(k) number is K253481.

When did colonic FTRD Set (200.70); diagnostic FTRD Set (200.76); gastroduodenal FTRD Set (200.72) receive FDA 510(k) clearance?

colonic FTRD Set (200.70); diagnostic FTRD Set (200.76); gastroduodenal FTRD Set (200.72) received FDA 510(k) clearance on 2026-09-14, under 510(k) number K253481.

Who is the listed applicant for colonic FTRD Set (200.70); diagnostic FTRD Set (200.76); gastroduodenal FTRD Set (200.72)?

The FDA 510(k) record lists Ovesco Endoscopy AG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for colonic FTRD Set (200.70); diagnostic FTRD Set (200.76); gastroduodenal FTRD Set (200.72)?

The FDA product code for colonic FTRD Set (200.70); diagnostic FTRD Set (200.76); gastroduodenal FTRD Set (200.72) is PKL.

Other records listing Ovesco Endoscopy AG as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K251562OTSCneo System Set (100.03n-14n, 100.27n-31n)K242586ArgoCap (200.52)K241858BARS Set (100.60)K221385LiftUp (Ref. Nr.: 200.56.01), LiftUp Kit (Ref. Nr.: 200.56.02)K200684gastroduodenal FTRD SetK183309stentfix OTSC System Set

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Related Devices (Code: PKL)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K254069Hemoclip (511 series, 543 series)Hangzhou AGS MedTech Co., Ltd.K260580Single Use Reloadable Clip Applicator (HX-810LR, HX-810UR); Clip (HX-610-090, HX-610-135); Long Clip (HX-610-090L, HX-610-135L); Short Clip (HX-610-090S, HX-610-135S); Super Short Clip (HX-610-135XS)Olympus Medical Systems Corp.K252270HemoclipHangzhou AGS MedTech Co., Ltd.K253734Taurus ClipTaurus EndoscopyK251562OTSCneo System Set (100.03n-14n, 100.27n-31n)Ovesco Endoscopy AGK252271HemoclipHangzhou AGS MedTech Co., Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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