# K252270: Hemoclip

- Pathway: 510(k) (Traditional)
- Applicant: Hangzhou AGS MedTech Co., Ltd.
- Decided: Apr 8, 2026 after 261 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: 8 generations back to K963160 (1997). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K202333: Lockado Repositionable Hemostasis Clip, Micro-Tech (Nanjing) Co., Ltd. (2021) Summary page 6.

## Indications for use
The Hemoclip is indicated for endoscopic clip placement within the digestive tract in adult populations only via a straight or side viewing flexible endoscope for the purpose of: 1. Endoscopic marking, 2. Hemostasis for: ● Mucosal/sub-mucosal defects <3cm ● Bleeding ulcers ● Arteries<2mm ● Polyps<l .5cm in diameter ● Diverticula in the colon 3. Anchoring to affixjejunal 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/K252270
Methodology: https://510kreport.com/methodology