Weck Hem-O-Lok Automatic Ligating Clip Applier

510(k) K021808

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

This device is named in the recall

Documents

FDA record

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

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK021808	Date14 Aug 2002Cleared	StatusActive

7 recalls · 1 ongoing · FDA

- Ongoing Z-0497-2020 FDA Class II initiated 4 Oct 2019
Certain clip appliers have an increase in misloading and/or jamming related complaints that may be due to a discrepancy in the specification a component. Misloading and/or jamming may lead to clips falling out of the applier, clip breakage, or the jaws becoming locked in a partially closed position (jammed).
5 recalls, same reason
- Terminated Z-0160-2009 FDA Unclassified (pre-2012) initiated 22 Aug 2008
- Terminated Z-0159-2009 FDA Unclassified (pre-2012) initiated 22 Aug 2008
- Terminated Z-0158-2009 FDA Unclassified (pre-2012) initiated 22 Aug 2008
- Terminated Z-0157-2009 FDA Unclassified (pre-2012) initiated 22 Aug 2008
- Terminated Z-0156-2009 FDA Unclassified (pre-2012) initiated 22 Aug 2008
A hole in the sterile unit blister pack was detected that would compromise sterility.
- Terminated Z-1099-06 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.

1 jurisdiction

United States — FDA 510(k) Active

510(k)