# K254069: Hemoclip (511 series, 543 series)

- Pathway: 510(k) (Traditional)
- Applicant: Hangzhou AGS MedTech Co., Ltd.
- Decided: Aug 10, 2026 after 235 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 5.

## 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<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 Gl tract luminal perforations<20mm that can be treated conservatively.

Source page: https://510kreport.com/device/K254069
Methodology: https://510kreport.com/methodology