# K220157: Disposable Hemostatic Closure Clip Device

- Pathway: 510(k) (Traditional)
- Applicant: Micro-Tech (Nanjing) Co., Ltd.
- Decided: Jun 13, 2022 after 145 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: 5 generations back to K963160 (1997). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101428: Otsc (Over-the Scope-Clip) System Set, Ovesco Endoscopy AG (2010) Summary page 5.

## Indications for use
The device for flexible endoscopy and for compression of tissue in the gastrointestinal (GI) tract, for hemostasis or for treating gastrointestinal organ wall lesions, and for making of lesions. The Device is indicated for clip placement within the GI tract for the purpose of: a .Endoscopic Marking b. Hemostasis for: - Mucosal/Submucosal defects < 3cm - Bleeding Ulcers - Arteries <2 mm - Polyps < 1.5 cm in diameter - Diverticula in the Colon c. Closure of GI tract luminal perforations < 20mm that can be treated conservatively.

Source page: https://510kreport.com/device/K220157
Methodology: https://510kreport.com/methodology