Cleared Special

K192722 - Padlock Clip defect closure system, Padlock Pro-Select defect closure device

K192722 is an FDA 510(k) clearance for Padlock Clip defect closure system, 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 27-day FDA review.

K192722 · STERIS Corporation · Gastroenterology & Urology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2019
Decision
27d
Days
Class 2
Risk

K192722 is an FDA 510(k) clearance for the Padlock Clip defect closure system, Padlock Pro-Select defect closure device. 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 October 24, 2019 after a review of 27 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 - K192722

510(k) Number K192722 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 27, 2019
Decision Date October 24, 2019
Days to Decision 27 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
104d faster than avg
Panel avg: 131d · This submission: 27d
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 K192722.
Resolution 360™ ULTRA Clip
K193424 · Boston Scientific Corporation · Sep 2020
gastroduodenal FTRD Set
K200684 · Ovesco Endoscopy AG · Jun 2020
Instinct Plus Endoscopic Clipping Device
K192697 · Cook Endoscopy · Mar 2020
stentfix OTSC System Set
K183309 · Ovesco Endoscopy AG · Oct 2019
Single Use Reloadable Clip Applicator, Clip, Long Clip, Short Clip, Super Short Clip
K183590 · Olympus Medical Systems Corp. · Aug 2019
ClearEndoclip
K183021 · Finemedix Co., Ltd. · Jun 2019
K192722 · Padlock Clip defect closure system, Padlock Pro-Select defect closure device
Download PDF FDA Summary STERIS Corporation