# K180689: Padlock Clip defect closure device; Padlock Clip Pro-Select defect closure device

- Pathway: 510(k) (Special)
- Applicant: STERIS Corporation
- Decided: Apr 12, 2018 after 28 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: 6 generations back to K963160 (1997). 8 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120814: Padlock Clip-12, Aponos Medical Corp. (2012) Summary page 5.

## Most influential descendants
- K192722: Padlock Clip defect closure system, Padlock Pro-Select defect closure device (2019), 0 descendants of its own

## 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/K180689
Methodology: https://510kreport.com/methodology