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Entuit Secure Gastrointestinal Suture Anchor Set, Entuit Secure Adjustable Gastrointestinal Suture Anchor Set

by Cook Incorporated

510(k) K152524

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

1 ongoing

This device is named in the recall

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK152524 Date30 Sep 2015ClearedStatusActive

Recalls

3 recalls · 1 ongoing · FDA

    • Ongoing Z-1529-2024 FDA Class II initiated 1 Mar 2024

    Packaging may have low seal strength and not meet peel strength specifications, compromising device sterility

  • 2 recalls, same reason

    • Terminated Z-0967-2019 FDA Class II initiated 19 Dec 2018
    • Terminated Z-0968-2019 FDA Class II initiated 19 Dec 2018

    There is a potential for difficulty in sliding down the retention mechanism on the sets manufactured with a specific extension spring lot.

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  • Withdrawn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
FGE
Device Class
Class II
Regulation
21 CFR Part 876.5010
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

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