# K230004: Disposable Hemoclip

- Pathway: 510(k) (Traditional)
- Applicant: Yangzhou Fartley Medical Instrument Technology Co., Ltd.
- Decided: Jul 31, 2023 after 209 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 4.

## Indications for use
The Disposable 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 affixjejunal feeding tubes to the wall of the small bowel 4. As a supplementary method, closure for GI tract luminal perforations <20mm that can be treated conservatively.

Source page: https://510kreport.com/device/K230004
Methodology: https://510kreport.com/methodology