# K982941: Hem-O-Lok Model Numbers 523900, 523970

- Pathway: 510(k) (Traditional)
- Applicant: Weck Closure Systems
- Decided: Nov 19, 1998 after 90 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: 1 generation back to K922186 (1992). 1 ancestor in all.
9 later devices descend from it; 2 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)
- K922186: Hem-O-Lok -- Modification, Linvatec Corp. (1992) Summary page 1.

## Most influential descendants
- K993157: Hem-O-Lok SMX Polymer Clips, Model 544220, Hem-0-Lok MLX Polymer Clips, Model 544240 (1999), 8 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
- K232970: Hem-o-lok® Ligating Clips (2024), 1 descendant of its own
- K250643: Disposable Polymer Ligation Clips (2025), 0 descendants of its own

## Recalls of this device
- Jan 23, 2004 · Not classified · Z-0547-04: Malformation of the Hem-o-lok SMX clip.

## Indications for use
Hem-0-Lok® ligating clips are intended for use in procedures involving ligation of vessels or tissue structures. Surgeons should match clip size to the size of the vessel or tissue structure to be ligated.

Source page: https://510kreport.com/device/K982941
Methodology: https://510kreport.com/methodology