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Ethicon Multiple Ligating Clip Applier

by Ethicon Inc.

510(k) K812291

Ethicon Multiple Ligating Clip Applier is a Class I device made by Ethicon Inc., cleared under FDA 510(k) K812291 on 11 Sep 1981, active as of 22 Oct 2026. 3 FDA recalls are linked to it.

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

3 closed

Documents

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK812291 Date11 Sep 1981ClearedStatusActive

Official records

Recalls

3 recalls · FDA

  • 3 recalls, same reason

    • Terminated Z-1775-2013 FDA Class II initiated 12 Apr 2013
    • Terminated Z-1776-2013 FDA Class II initiated 12 Apr 2013
    • Terminated Z-1777-2013 FDA Class II initiated 12 Apr 2013

    Ethicon Endo-Surgery is initiating a voluntary recall for LIGACLIP 10mm M/L Endoscopic Rotating Multiple Clip Applier (ER320) due to potential clip formation and feeding issues which may result in improper clip formation, vessel damage and/or insufficient occlusion of the vessel or other structure

Timeline

4 dated events

  1. Cleared FDA 510(k) K812291
  2. Recall initiated FDA recalls Z-1775-2013
  3. Recall initiated FDA recalls Z-1776-2013
  4. Recall initiated FDA recalls Z-1777-2013

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  • Withdrawn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
GDO
FDA applicant
ETHICON, Inc.
Device class
Class I
Regulation
21 CFR Part 878.4800
Advisory committee
General, Plastic Surgery
FDA decision
SESE Substantially Equivalent

Similar devices

Other devices filed under FDA product code GDO (Applier, Surgical, Clip).

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