# K232969: Disposable Hemostatic Clips

- Pathway: 510(k) (Traditional)
- Applicant: Ningbo Xinwell Medical Technology Co., Ltd.
- Decided: Jun 7, 2024 after 260 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 6.

## Indications for use
The Disposable Hemostatic Clips is indicated for Endoscopic clip placement within the Gastrointestinal tract in adult populations only via a straight or side viewing flexible endoscope for the purpose of : 1) Endoscopic marking; 2) Hemostasis for: A) Mucosal/sub-mucosal defects < 3cm. B) Bleeding ulcers. C) Polyps < 1.5cm in diameter. D) Diverticula in the colon. E) Arteries < 2 mm. F) Prophylactic clipping to reduce the risk of delayed bleeding post lesion resection. 3) As a supplementary method, closure of GI tract luminal perforations <20mm that can be treated conservatively 4) Anchoring to affix jejunal feeding tubes to the wall of the small bowel

Source page: https://510kreport.com/device/K232969
Methodology: https://510kreport.com/methodology