Cleared Traditional

K120814 - PADLOCK CLIP-12

K120814 is an FDA 510(k) clearance for PADLOCK CLIP-12, manufactured by Aponos Medical Corp.. The device is a Class 2 Gastroenterology & Urology device with product code PKL cleared through the Traditional 510(k) pathway after a 171-day FDA review.

K120814 · Aponos Medical Corp. · Gastroenterology & Urology device
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Optimized for regulatory review, auditing and printing
Sep 2012
Decision
171d
Days
Class 2
Risk

K120814 is an FDA 510(k) clearance for the PADLOCK CLIP-12. Classified as Hemostatic Metal Clip For The Gi Tract (product code PKL), Class II - Special Controls.

Submitted by Aponos Medical Corp. (Kingston, US). The FDA issued a Cleared decision on September 6, 2012 after a review of 171 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.4400 - the FDA gastroenterology and urology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Aponos Medical Corp. devices

FDA 510(k) Submission Details - K120814

510(k) Number K120814 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 19, 2012
Decision Date September 06, 2012
Days to Decision 171 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
41d slower than avg
Panel avg: 130d · This submission: 171d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 55
Devices cleared under the same product code (PKL) and FDA review panel - the closest regulatory comparables to K120814.
INSTINCT ENDOSCOPIC HEMOCLIP
K132809 · Wilson-Cook Medical, Inc. · Oct 2013
SINGLE USE REPOSITIONABLE CLIP
K123601 · Olympus Medical Systems Corp. · Apr 2013
RESOLUTION CLIP MODEL M00522600, M00522601, M00522602, M00522610, M00522611, M00522612
K122660 · Boston Scientific Corporation · Dec 2012
RESOLUTION II CLIP
K102764 · Boston Scientific Corporation · Dec 2010
WILSON-COOK ENDOSCOPIC CLIPPING DEVICE
K023903 · Wilson-Cook Medical, Inc. · Feb 2003
HX-5/6-1 ENDOSCOPIC CLIPPING DEVICE
K963160 · Olympus America, Inc. · Jun 1997