# K241005: Haemostasis Clips

- Pathway: 510(k) (Traditional)
- Applicant: Jiangxi Zhuoruihua Medical Instrument Co., Ltd.
- Decided: Jan 2, 2025 after 265 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 Haemostasis Clips are 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; Prophylactic clipping to reduce the risk of delayed bleeding post lesion resection. 3.Anchoring to affix jejunal feeding tubes to the wall of the small bowel; 4.As a supplementary method, closure for Gl tract luminal perforations<20mm that can be treated conservatively.

Source page: https://510kreport.com/device/K241005
Methodology: https://510kreport.com/methodology