Cleared Special

K250842 - PADLOCK CLIP EFTR Kit (00713229)

K250842 is an FDA 510(k) clearance for PADLOCK CLIP EFTR Kit (00713229), manufactured by STERIS Corporation. The device is a Class 2 Gastroenterology & Urology device with product code PKL cleared through the Special 510(k) pathway after a 29-day FDA review.

K250842 · STERIS Corporation · Gastroenterology & Urology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2025
Decision
29d
Days
Class 2
Risk

K250842 is an FDA 510(k) clearance for the PADLOCK CLIP EFTR Kit (00713229). Classified as Hemostatic Metal Clip For The Gi Tract (product code PKL), Class II - Special Controls.

Submitted by STERIS Corporation (Mentor, US). The FDA issued a Cleared decision on April 18, 2025 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.4400 - the FDA gastroenterology and urology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K250842

510(k) Number K250842 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
102d faster than avg
Panel avg: 131d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

PKL Device Classification - Class 2, Special Controls

Product Code PKL Hemostatic Metal Clip For The Gi Tract
Device Class Class 2 - 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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - PKL Hemostatic Metal Clip For The Gi Tract

All 66
Devices cleared under the same product code (PKL) and FDA review panel - the closest regulatory comparables to K250842.
OTSCneo System Set (100.03n-14n, 100.27n-31n)
K251562 · Ovesco Endoscopy AG · Dec 2025
Hemoclip
K252271 · Hangzhou AGS MedTech Co., Ltd. · Nov 2025
Dual Action Tissue Closure Device
K250229 · Micro-Tech (Nanjing) Co., Ltd. · Sep 2025
Resolution Clip (M00522600)
K250066 · Boston Scientific Corporation · Feb 2025
Haemostasis Clips
K241005 · Jiangxi Zhuoruihua Medical Instrument Co., Ltd. · Jan 2025
PADLOCK CLIP EFTR Kit (00713229)
K240274 · STERIS Corporation · Sep 2024
K250842 · PADLOCK CLIP EFTR Kit (00713229)
Download PDF FDA Summary STERIS Corporation