# K231633: Disposable Hemoclip (AF series)

- Pathway: 510(k) (Traditional)
- Applicant: Alton (Shanghai) Medical Instruments Co., Ltd.
- Decided: Jan 11, 2024 after 220 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)
- K172727: Hemoclip, Hangzhou AGS MedTech Co., Ltd. (2018) Summary page 5.

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

Source page: https://510kreport.com/device/K231633
Methodology: https://510kreport.com/methodology