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Auto Suture Titanium Surgical Staples

by United States Surgical, A Division of Tyco Healthc

510(k) K855047

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

5 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 NumberK855047 Date14 Jan 1986ClearedStatusActive

Recalls

5 recalls · FDA

  • 5 recalls, same reason

    • Terminated Z-1845-2012 FDA Class II initiated 9 May 2012
    • Terminated Z-1844-2012 FDA Class II initiated 9 May 2012
    • Terminated Z-1846-2012 FDA Class II initiated 9 May 2012
    • Terminated Z-1847-2012 FDA Class II initiated 9 May 2012
    • Terminated Z-1848-2012 FDA Class II initiated 9 May 2012

    Potential for the sterility barrier to be compromised.

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  • Withdrawn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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