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Auto Suture Endo Gia Staplers with Endo Gia Single Use Loading Units with Staple Line Reinforcement

by Tyco Healthcare Group LP

510(k) K080898

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

24 closed

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 · Traditional NumberK080898 Date5 May 2008ClearedStatusActive

Recalls

24 recalls · FDA

  • 5 recalls, same reason

    • Terminated Z-2437-2012 FDA Class II initiated 21 Aug 2012
    • Terminated Z-2435-2012 FDA Class II initiated 21 Aug 2012
    • Terminated Z-2432-2012 FDA Class II initiated 21 Aug 2012
    • Terminated Z-2438-2012 FDA Class II initiated 21 Aug 2012
    • Terminated Z-2436-2012 FDA Class II initiated 21 Aug 2012

    Duet TRS may have the potential to injure adjacent anatomical structures which may result in life threatening post-operative complications

  • 3 recalls, same reason

    • Terminated Z-2433-2012 FDA Class II initiated 21 Aug 2012
    • Terminated Z-2434-2012 FDA Class II initiated 21 Aug 2012
    • Terminated Z-2439-2012 FDA Class II initiated 21 Aug 2012

    Duet TRS may have the potential to injure adjacent anatomical structures which may result in life threatening post-operative complications.

    • Terminated Z-1227-2012 FDA Not yet classified initiated 16 Feb 2012

    Missing component results in the stapler not firing.

  • 7 recalls, same reason

    • Terminated Z-0992-2012 FDA Not yet classified initiated 12 Jan 2012
    • Terminated Z-0996-2012 FDA Not yet classified initiated 12 Jan 2012
    • Terminated Z-0998-2012 FDA Not yet classified initiated 12 Jan 2012
    • Terminated Z-0994-2012 FDA Not yet classified initiated 12 Jan 2012
    • Terminated Z-0991-2012 FDA Not yet classified initiated 12 Jan 2012
    • Terminated Z-0995-2012 FDA Not yet classified initiated 12 Jan 2012
    • Terminated Z-0993-2012 FDA Not yet classified initiated 12 Jan 2012

    Duet TRS Straight and Articulating Single Use (SULU)Loading Staplers used in thoracic surgery may result in serious injury or death

  • 8 recalls, same reason

    • Terminated Z-3164-2011 FDA Unclassified (pre-2012) initiated 15 Aug 2011
    • Terminated Z-3167-2011 FDA Unclassified (pre-2012) initiated 15 Aug 2011
    • Terminated Z-3171-2011 FDA Unclassified (pre-2012) initiated 15 Aug 2011
    • Terminated Z-3165-2011 FDA Unclassified (pre-2012) initiated 15 Aug 2011
    • Terminated Z-3168-2011 FDA Unclassified (pre-2012) initiated 15 Aug 2011
    • Terminated Z-3169-2011 FDA Unclassified (pre-2012) initiated 15 Aug 2011
    • Terminated Z-3166-2011 FDA Unclassified (pre-2012) initiated 15 Aug 2011
    • Terminated Z-3170-2011 FDA Unclassified (pre-2012) initiated 15 Aug 2011

    Sterility of the device is compromised due to a breach in the sterile packaging

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
GDW
Device Class
Class II
Regulation
21 CFR Part 878.4750
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

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