# K250842: PADLOCK CLIP EFTR Kit (00713229)

- Pathway: 510(k) (Special)
- Applicant: STERIS Corporation
- Decided: Apr 18, 2025 after 29 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: 2 generations back to K170867 (2017). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K240274: PADLOCK CLIP EFTR Kit (00713229), STERIS Corporation (2024) Summary page 5.

## Indications for use
The PADLOCK CLIP™ EFTR Device is an electrosurgical device that is designed for a flexible endoscope. It is intended for diagnostic tissue acquisition and full-thickness resection through the removal of lesions in the colon and rectum. The PADLOCK CLIP™ EFTR Device is indicated for the resection of lesions less than 3cm in the colon and rectum. Resection sizes may be less than 3cm due to targeted tissue thickness and degree of fibrosis. The disposable RAPTOR Grasping Device is intended to be used to grasp tissue and/or retrieve foreign bodies, excised tissue and stents during endoscopic procedures. The TOUCHSOFT Coagulator is used to provide monopolar therapeutic hemostasis and tissue ablation in the gastrointestinal tract through a flexible endoscope by a trained physician or clinician.

Source page: https://510kreport.com/device/K250842
Methodology: https://510kreport.com/methodology