# K222146: Disposable Endoscopic Hemoclip

- Pathway: 510(k) (Traditional)
- Applicant: Jiangsu Vedkang Medical Science and Technology Co., Ltd.
- Decided: Mar 28, 2023 after 251 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)
- K182556: SureClip Repositionable Hemostasis Clip, Micro-Tech (Nanjing) Co., Ltd. (2018) Summary page 6.

## Indications for use
It is indicated for Endoscopic clip placement within the Gastrointestinal tract in adult patients 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

Source page: https://510kreport.com/device/K222146
Methodology: https://510kreport.com/methodology