Skip to content

Surgical Clamp Inserts

by Applied Vascular Devices, Inc.

510(k) K883790

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

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 NumberK883790 Date27 Dec 1988ClearedStatusActive

Recalls

3 recalls · FDA

  • 3 recalls, same reason

    • Terminated Z-3006-2011 FDA Unclassified (pre-2012) initiated 7 Mar 2011
    • Terminated Z-3005-2011 FDA Unclassified (pre-2012) initiated 7 Mar 2011
    • Terminated Z-3004-2011 FDA Unclassified (pre-2012) initiated 7 Mar 2011

    The recall was initiated because Applied Medical has confirmed that Surgical Clamp Inserts, Model Numbers: G-8600, G-8650, G-8655, has the potential packaging nonconformance which could result in a compromise to the sterile barrier.

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  • Withdrawn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
DXC
Device Class
Class II
Regulation
21 CFR Part 870.4450
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Other devices from Applied Vascular Devices, Inc.

See all devices from Applied Vascular Devices, Inc. →