# K213217: Disposable hemoclip

- Pathway: 510(k) (Traditional)
- Applicant: Beijing Zksk Technology Co., Ltd.
- Decided: Nov 14, 2022 after 411 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)
- K201771: Single Use Rotatable and Repositionable Hemoclip, Anrei Medical (Hangzhou) Co., Ltd. (2020) Summary page 5.

## Indications for use
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 <3cm, Bleeding ulcers, Arteries < 2mm, Polyps < 1.5cm in diameter, Diverticula in the colon, 3）As a supplementary method, closure of GI tract luminal perforations < 20mm that can be treated conservatively.

Source page: https://510kreport.com/device/K213217
Methodology: https://510kreport.com/methodology