# K192722: Padlock Clip defect closure system, Padlock Pro-Select defect closure device

- Pathway: 510(k) (Special)
- Applicant: STERIS Corporation
- Decided: Oct 24, 2019 after 27 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: 7 generations back to K963160 (1997). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K180689: Padlock Clip defect closure device; Padlock Clip Pro-Select defect closure device, STERIS Corporation (2018) Summary page 5.

## Indications for use
The Padlock Clip™ is indicated for use in flexible Endoscopy and for the compression of tissue in the gastrointestinal tract, for hemostasis or for treating lesions of the wall of the gastrointestinal organs. The Padlock Clip™ is indicated for clip placement within the gastrointestinal (GI) tract for the purpose of: • Endoscopic marking of lesions • Hemostasis for: o Mucosal/Submucosal defects o Bleeding Ulcers o Arteries <2mm o Polyps <1.5cm in diameter o Diverticula in the Colon • Closure of GI tract luminal perforations <20mm that can be treated conservatively

Source page: https://510kreport.com/device/K192722
Methodology: https://510kreport.com/methodology