# K993157: Hem-O-Lok SMX Polymer Clips, Model 544220, Hem-0-Lok MLX Polymer Clips, Model 544240

- Pathway: 510(k) (Traditional)
- Applicant: Weck Closure Systems
- Decided: Dec 17, 1999 after 87 days
- Product code: FZP (Clip, Implantable)
- Device class: 2
- Regulation: 21 CFR 878.4300
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K922186 (1992). 2 ancestors in all.
8 later devices descend from it; 4 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K982941: Hem-O-Lok Model Numbers 523900, 523970, Weck Closure Systems (1998) Summary page 1.

## Most influential descendants
- K062914: Hem-O-Lok Ligation Clip (2006), 4 descendants of its own
- K133202: Hem-O-Lok Ligating Clip (2013), 3 descendants of its own
- K232970: Hem-o-lok® Ligating Clips (2024), 1 descendant of its own
- K250643: Disposable Polymer Ligation Clips (2025), 0 descendants of its own
- K251054: Hem-o-lok™ PurplePlus™ Large Polymer Ligating Clips (2025), 0 descendants of its own

## Recalls of this device
- Sep 25, 2012 · Class II · Z-0078-2013: Product is being recalled due to the possibility that the tray may contain pinholes, compromising product sterility.

## Indications for use
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 structure to be ligated such that the clip completely encompasses the vessel or tissue structure.

Source page: https://510kreport.com/device/K993157
Methodology: https://510kreport.com/methodology