# K211787: Hemoclip

- Pathway: 510(k) (Traditional)
- Applicant: Hangzhou AGS MedTech Co., Ltd.
- Decided: Mar 3, 2022 after 267 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.
2 later devices descend from it; 2 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172727: Hemoclip, Hangzhou AGS MedTech Co., Ltd. (2018) Summary page 4.

## Most influential descendants
- K252271: Hemoclip (2025), 0 descendants of its own
- K234124: Single Use Hemoclips (2024), 0 descendants of its own

## Indications for use
The Hemoclip is indicated for endoscopic clip placement within the gastrointestinal tract for the purpose of: I. Endoscopic marking, 2. Hemostasis for: • Mucosal/sub-mucosal defects <3cm • Bleeding ulcers • Arteries<2mm • Polyps<l .5cm in diameter • Diverticula in the colon • Prophylactic clipping to reduce the risk of delayed bleeding post lesion resection 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/K211787
Methodology: https://510kreport.com/methodology