# K250229: Dual Action Tissue Closure Device

- Pathway: 510(k) (Traditional)
- Applicant: Micro-Tech (Nanjing) Co., Ltd.
- Decided: Sep 8, 2025 after 224 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: 10 generations back to K963160 (1997). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K233772: Disposable Dual Action Tissue Closure Device, Mirco-Tech (Nanjing) Co., Ltd. (2024) Summary page 6.

## Indications for use
The Dual Action Tissue Closure Device is intended for use in flexible endoscopy for the compression of tissue in the gastrointestinal tract. The Dual Action Tissue Closure Device is indicated for clip placement within the gastrointestinal tract for the purpose of: Endoscopic marking, Hemostasis for Mucosal/sub-mucosal defects < 5 cm, Bleeding ulcers, Polyps < 1.5 cm in diameter, Diverticula in the colon, Arteries < 2 mm, As a supplementary method, closure of GI tract luminal perforations < 20 mm that can be treated conservatively.

Source page: https://510kreport.com/device/K250229
Methodology: https://510kreport.com/methodology