# K021808: Weck Hem-O-Lok Automatic Ligating Clip Applier

- Pathway: 510(k) (Traditional)
- Applicant: Weck
- Decided: Aug 14, 2002 after 72 days
- Product code: FZP (Clip, Implantable)
- Device class: 2
- Regulation: 21 CFR 878.4300
- Recalls of this device: 7 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
11 later devices descend from it; 2 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Weck Hem-o-lok clips: named in the summary without a submission number
- (no number) U.S.S.C. Autosuture Endoclip 5mm Disposable Clip Applier: named in the summary without a submission number
- (no number) Weck reusable ligating clip appliers: named in the summary without a submission number

## Most influential descendants
- K142777: Weck Hem-o-lok Auto Endo5 Ligating Clip Applier (2014), 5 descendants of its own
- K152081: Weck Auto Endo5 Hem-o-lok Ligating Clip Applier (2015), 4 descendants of its own
- K062914: Hem-O-Lok Ligation Clip (2006), 4 descendants of its own
- K133202: Hem-O-Lok Ligating Clip (2013), 3 descendants of its own
- K230480: Weck Auto Endo5 5mm Automatic Endoscopic 35cm Applier (AE05ML) (2023), 2 descendants of its own

## Recalls of this device
- Oct 4, 2019 · Class II · Z-0497-2020: 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 fa
- Aug 22, 2008 · Not classified · Z-0158-2009: A hole in the sterile unit blister pack was detected that would compromise sterility.
- Aug 22, 2008 · Not classified · Z-0160-2009: A hole in the sterile unit blister pack was detected that would compromise sterility.
- Aug 22, 2008 · Not classified · Z-0157-2009: A hole in the sterile unit blister pack was detected that would compromise sterility.
- Aug 22, 2008 · Not classified · Z-0156-2009: A hole in the sterile unit blister pack was detected that would compromise sterility.
- Aug 22, 2008 · Not classified · Z-0159-2009: A hole in the sterile unit blister pack was detected that would compromise sterility.
- Apr 12, 2006 · Not classified · Z-1099-06: 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 

## Indications for use
Weck Hem-o-lok Automatic Ligating Clip Appliers are indicated for use as delivery devices for Hem-o-lok non-absorbable polymer ligating clips. Hem-o-lok ligating clips are intended for use in procedures involving ligation of vessels or tissue structures. Surgeons should apply the appropriate size clip for the size of the vessel or tissue structures to be ligated such that the clip completely encompasses the vessel or tissue structure.

Source page: https://510kreport.com/device/K021808
Methodology: https://510kreport.com/methodology