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Auto Suture Surgical Staples

by United States Surgical, A Division of Tyco Healthc

510(k) K013860

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

8 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 · Special NumberK013860 Date19 Dec 2001ClearedStatusActive

Recalls

8 recalls · FDA

  • 8 recalls, same reason

    • Terminated Z-0962-04 FDA Unclassified (pre-2012) initiated 5 May 2004
    • Terminated Z-0964-04 FDA Unclassified (pre-2012) initiated 5 May 2004
    • Terminated Z-0959-04 FDA Unclassified (pre-2012) initiated 5 May 2004
    • Terminated Z-0961-04 FDA Unclassified (pre-2012) initiated 5 May 2004
    • Terminated Z-0966-04 FDA Unclassified (pre-2012) initiated 5 May 2004
    • Terminated Z-0958-04 FDA Unclassified (pre-2012) initiated 5 May 2004
    • Terminated Z-0963-04 FDA Unclassified (pre-2012) initiated 5 May 2004
    • Terminated Z-0960-04 FDA Unclassified (pre-2012) initiated 5 May 2004

    Stapler may clamp without the staples being fired into the tissue

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  • Withdrawn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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