# K240274: PADLOCK CLIP EFTR Kit (00713229)

- Pathway: 510(k) (Traditional)
- Applicant: STERIS Corporation
- Decided: Sep 17, 2024 after 230 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: 1 generation back to K170867 (2017). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170867: FTRD System Set, Ovesco Endoscopy AG (2017) Summary page 6.

## Most influential descendants
- K250842: PADLOCK CLIP EFTR Kit (00713229) (2025), 0 descendants of its own

## Indications for use
The PADLOCK CLIP ™ EFTR Device is a 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/K240274
Methodology: https://510kreport.com/methodology