Skip to content

Hem-O-Lok Smx, Model 544220; Hem-O-Lok Ml, Model 544230; Hem-O-Lok Mlx, Model 544240

by Weck Closure Systems

510(k) K003337

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

2 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 NumberK003337 Date21 Dec 2000ClearedStatusActive

Recalls

2 recalls · FDA

  • 2 recalls, same reason

    • Terminated Z-1096-06 FDA Unclassified (pre-2012) initiated 12 Apr 2006
    • Terminated Z-1097-06 FDA Unclassified (pre-2012) initiated 12 Apr 2006

    The Hem-o-lok ligating clips may become dislodged following ligation of the renal artery after laparoscopic donor nephrectomy. Hem-o-lok ligating clips are now contraindicated for use in ligating the renal artery during laparascopic nephrectomies in living donor patients.

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  • Withdrawn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

Other devices from Weck Closure Systems