# K252271: Hemoclip

- Pathway: 510(k) (Traditional)
- Applicant: Hangzhou AGS MedTech Co., Ltd.
- Decided: Nov 12, 2025 after 114 days
- Product code: PKL (Hemostatic Metal Clip For The Gi Tract)
- Device class: 2
- Regulation: 21 CFR 876.4400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K963160 (1997). 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)
- K211787: Hemoclip, Hangzhou AGS MedTech Co., Ltd. (2022) Summary page 5.

## Indications for use
The hemoclip is indicated for endoscopic clip placement within the gastrointestinal tract for the purpose of: 1. Endoscopic marking, 2. Hemostasis for: • Mucosal/sub-mucosal defects <3cm • Bleeding ulcers • Arteries<2mm • Polyps<1.5cm in diameter • Diverticula in the colon 3. Anchoring to affix jejunal feeding tubes to the wall of the small bowel. 4. As a supplementary method, closure of GI tract luminal perforations<20mm that can be treated conservatively.

Source page: https://510kreport.com/device/K252271
Methodology: https://510kreport.com/methodology