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Microsurge Detacha-Tip Surgical Instruments

by Microsurge, Inc.

510(k) K924283

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

12 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 NumberK924283 Date7 Apr 1993ClearedStatusActive

Recalls

12 recalls · FDA

  • 10 recalls, same reason

    • Terminated Z-0091-2007 FDA Unclassified (pre-2012) initiated 12 Oct 2006
    • Terminated Z-0085-2007 FDA Unclassified (pre-2012) initiated 12 Oct 2006
    • Terminated Z-0086-2007 FDA Unclassified (pre-2012) initiated 12 Oct 2006
    • Terminated Z-0088-2007 FDA Unclassified (pre-2012) initiated 12 Oct 2006
    • Terminated Z-0083-2007 FDA Unclassified (pre-2012) initiated 12 Oct 2006
    • Terminated Z-0092-2007 FDA Unclassified (pre-2012) initiated 12 Oct 2006
    • Terminated Z-0089-2007 FDA Unclassified (pre-2012) initiated 12 Oct 2006
    • Terminated Z-0090-2007 FDA Unclassified (pre-2012) initiated 12 Oct 2006
    • Terminated Z-0084-2007 FDA Unclassified (pre-2012) initiated 12 Oct 2006
    • Terminated Z-0087-2007 FDA Unclassified (pre-2012) initiated 12 Oct 2006

    The grasper jaws broke during laparoscopic procedures at the junction of the jaw and the tube.

  • 2 recalls, same reason

    • Terminated Z-1434-06 FDA Unclassified (pre-2012) initiated 27 Mar 2006
    • Terminated Z-1433-06 FDA Unclassified (pre-2012) initiated 27 Mar 2006

    Grasper jaws breaking at the junction of the jaw and tube during laparoscopic procedures.

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  • Withdrawn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
GEI
Device Class
Class II
Regulation
21 CFR Part 878.4400
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

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