# K120814: Padlock Clip-12

- Pathway: 510(k) (Traditional)
- Applicant: Aponos Medical Corp.
- Decided: Sep 6, 2012 after 171 days
- Product code: PKL (Hemostatic Metal Clip For The Gi Tract)
- Device class: 2
- Regulation: 21 CFR 876.4400
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K963160 (1997). 7 ancestors in all.
2 later devices descend 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)
- K101428: Otsc (Over-the Scope-Clip) System Set, Ovesco Endoscopy AG (2010) Summary page 1.

## Most influential descendants
- K180689: Padlock Clip defect closure device; Padlock Clip Pro-Select defect closure device (2018), 1 descendant of its own
- K192722: Padlock Clip defect closure system, Padlock Pro-Select defect closure device (2019), 0 descendants of its own

## Recalls of this device
- Feb 4, 2019 · Class II · Z-1011-2019: Potential esophageal laceration during a patient procedure

## Indications for use
The Aponos Medical 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 gastrointestinal organs. The Padlock Clip is indicated for clip placement within the Gastro-intestinal (GI) tract for the purpose of: . Endoscopic marking of lesions. . Hemostasis for o Mucosal/Sub mucosal defects o Bleeding Ulcers o Arteries <2mm o Polyps <1.5cm diameter o Diverticula in the Colon . Closure of GI tract luminal perforations < 20mm that can be treated conservatively.

Source page: https://510kreport.com/device/K120814
Methodology: https://510kreport.com/methodology