Cleared Special

PADLOCK CLIP EFTR Kit (00713229)

K250842 · STERIS Corporation · Gastroenterology & Urology

Apr 2025

Decision

29d

Days

Class 2

Risk

About This 510(k) Submission

K250842 is an FDA 510(k) clearance for the PADLOCK CLIP EFTR Kit (00713229), a Hemostatic Metal Clip For The Gi Tract (Class II — Special Controls, product code PKL), submitted by STERIS Corporation (Mentor, US). The FDA issued a Cleared decision on April 18, 2025, 29 days after receiving the submission on March 20, 2025. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.4400.

Submission Details

510(k) Number	K250842 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 20, 2025
Decision Date	April 18, 2025
Days to Decision	29 days
Submission Type	Special
Review Panel	Gastroenterology & Urology (GU)
Summary	Summary PDF

Device Classification

Product Code	PKL — Hemostatic Metal Clip For The Gi Tract
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 876.4400
Definition	Clip Placement Within The Gastrointestinal (gi) Tract For The Purpose Of Endoscopic Marking, Hemostasis For Mucosal/sub-mucosal Defects, Bleeding Ulcers, Arteries, Polyps, Diverticula In The Colon, Prophylactic Clipping, Anchoring Feeding Tubes, Supplemental Closure Method Of Luminal Perforations.