# K922186: Hem-O-Lok -- Modification

- Pathway: 510(k) (Traditional)
- Applicant: Linvatec Corp.
- Decided: Aug 6, 1992 after 161 days
- Product code: GDW (Staple, Implantable)
- Device class: 2
- Regulation: 21 CFR 878.4750
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
10 later devices descend from it; 1 cites 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)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K982941: Hem-O-Lok Model Numbers 523900, 523970 (1998), 9 descendants of its own
- 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

Source page: https://510kreport.com/device/K922186
Methodology: https://510kreport.com/methodology