# K233772: Disposable Dual Action Tissue Closure Device

- Pathway: 510(k) (Traditional)
- Applicant: Mirco-Tech (Nanjing) Co., Ltd.
- Decided: Mar 19, 2024 after 116 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: 9 generations back to K963160 (1997). 9 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K212748: Disposable Dual Action Tissue Clip, Micro-Tech (Nanjing) Co., Ltd. (2022) Summary page 6.

## Most influential descendants
- K250229: Dual Action Tissue Closure Device (2025), 0 descendants of its own

## Indications for use
The Disposable Dual Action Tissue Closure Device is intended for use in flexible endoscopy for the compression of tissue in the gastrointestinal tract for adult patient only. The Disposable Dual Action Tissue Closure Device is indicated for clip placement within the gastrointestinal tract for the purpose of: 1. Endoscopic marking; 2. Hemostasis for: a.Mucosal/sub-mucosal defects< 5 cm, b.Bleeding ulcers, c.Polyps< 1.5 cm in diameter, d.Diverticula in the colon, e.Arteries< 2 mm, 3. As a supplementary method, closure of GI tract luminal perforations< 20 mm that can be treated conservatively.

Source page: https://510kreport.com/device/K233772
Methodology: https://510kreport.com/methodology