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Hem-O-Lok Smx Polymer Clips, Model 544220, Hem-0-Lok Mlx Polymer Clips, Model 544240

by Weck Closure Systems

510(k) K993157

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 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 NumberK993157 Date17 Dec 1999ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-0078-2013 FDA Class II initiated 25 Sep 2012

    Product is being recalled due to the possibility that the tray may contain pinholes, compromising product sterility.

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  • Withdrawn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
FZP
Models / Variants
Device Class
Class II
Regulation
21 CFR Part 878.4300
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

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