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colonic FTRD Set (200.70)

by Ovesco Endoscopy AG

510(k) K253481

colonic FTRD Set (200.70) is a Class II device made by Ovesco Endoscopy AG, cleared under FDA 510(k) K253481 on 14 Sep 2026, active as of 13 Nov 2026.

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 13 Nov 2026

Documents

Trust

Unverified

Source FDA 510(k), synced 13 Nov 2026.

Regulatory status

as of registry sync 13 Nov 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK253481 Date14 Sep 2026ClearedStatusActive

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
PKL
Device class
Class II
Regulation
21 CFR Part 876.4400
Advisory committee
Gastroenterology, Urology
FDA decision
SESE Substantially Equivalent

Similar devices

Other devices filed under FDA product code PKL (Hemostatic Metal Clip For The Gi Tract).

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