# K212748: Disposable Dual Action Tissue Clip

- Pathway: 510(k) (Traditional)
- Applicant: Micro-Tech (Nanjing) Co., Ltd.
- Decided: Jan 20, 2022 after 143 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.
2 later devices descend 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)
- K202333: Lockado Repositionable Hemostasis Clip, Micro-Tech (Nanjing) Co., Ltd. (2021) Summary page 5.

## Most influential descendants
- K233772: Disposable Dual Action Tissue Closure Device (2024), 1 descendant of its own
- K250229: Dual Action Tissue Closure Device (2025), 0 descendants of its own

## Indications for use
The Disposable Dual Action Tissue Clip 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 Clip is indicated for clip placement within the gastrointestinal tract for the purpose of: Endoscopic marking, Hemostasis for °Mucosal/sub-mucosal defects < 3 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/K212748
Methodology: https://510kreport.com/methodology