# K062914: Hem-O-Lok Ligation Clip

- Pathway: 510(k) (Traditional)
- Applicant: Teleflex Medical
- Decided: Nov 2, 2006 after 36 days
- Product code: FZP (Clip, Implantable)
- Device class: 2
- Regulation: 21 CFR 878.4300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K922186 (1992). 6 ancestors in all.
4 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)
- K982941: Hem-O-Lok Model Numbers 523900, 523970, Weck Closure Systems (1998) Summary page 1.
- K993157: Hem-O-Lok SMX Polymer Clips, Model 544220, Hem-0-Lok MLX Polymer Clips, Model 544240, Weck Closure Systems (1999) Summary page 1.
- K003337: Hem-O-Lok SMX, Model 544220; Hem-O-Lok ML, Model 544230; Hem-O-Lok MLX, Model 544240, Weck Closure Systems (2000) Summary page 1.
- K030311: Hem-O-Lok XL Clip, Weck (2003) Summary page 1.
- K021808: Weck Hem-O-Lok Automatic Ligating Clip Applier, Weck (2002) Summary page 1.

## Most influential descendants
- K133202: Hem-O-Lok Ligating Clip (2013), 3 descendants of its own
- K232970: Hem-o-lok® Ligating Clips (2024), 1 descendant of its own
- K251054: Hem-o-lok™ PurplePlus™ Large Polymer Ligating Clips (2025), 0 descendants of its own
- K181852: Percuvance Percutaneous Surgical System (2018), 0 descendants of its own

## 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/K062914
Methodology: https://510kreport.com/methodology