# K250643: Disposable Polymer Ligation Clips

- Pathway: 510(k) (Traditional)
- Applicant: Hangzhou Kangji Medical Instrument Co., Ltd.
- Decided: Nov 20, 2025 after 261 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: 4 generations back to K021808 (2002). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K993157: Hem-O-Lok SMX Polymer Clips, Model 544220, Hem-0-Lok MLX Polymer Clips, Model 544240, Weck Closure Systems (1999) Summary page 6.
- K230480: Weck Auto Endo5 5mm Automatic Endoscopic 35cm Applier (AE05ML), Teleflex Medical (2023) Summary page 6.

## Indications for use
The Disposable Polymer Ligation 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/K250643
Methodology: https://510kreport.com/methodology