# K251054: Hem-o-lok™ PurplePlus™ Large Polymer Ligating Clips

- Pathway: 510(k) (Traditional)
- Applicant: Teleflex Medical
- Decided: Jul 3, 2025 after 90 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: 6 generations back to K922186 (1992). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K232970: Hem-o-lok® Ligating Clips, Teleflex Medical (2024) Summary page 6.

## Indications for use
The Hem-o-lok™ PurplePlus™ Large Polymer Ligating Clips are intended for use in procedures involving the 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/K251054
Methodology: https://510kreport.com/methodology