Cleared Special

K132809 - INSTINCT ENDOSCOPIC HEMOCLIP

K132809 is the FDA 510(k) clearance for INSTINCT ENDOSCOPIC HEMOCLIP by Wilson-Cook Medical, Inc.. It is a Class 2 Gastroenterology & Urology device (product code PKL) cleared through the Special 510(k) pathway after a 46-day FDA review.

K132809 · Wilson-Cook Medical, Inc. · Gastroenterology & Urology device
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Oct 2013
Decision
46d
Days
Class 2
Risk

K132809 is an FDA 510(k) clearance for the INSTINCT ENDOSCOPIC HEMOCLIP. Classified as Hemostatic Metal Clip For The Gi Tract (product code PKL), Class II - Special Controls.

Submitted by Wilson-Cook Medical, Inc. (Winston-Salem, US). The FDA issued a Cleared decision on October 25, 2013 after a review of 46 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.

View all Wilson-Cook Medical, Inc. devices

Submission Details

510(k) Number K132809 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 09, 2013
Decision Date October 25, 2013
Days to Decision 46 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
84d faster than avg
Panel avg: 130d · This submission: 46d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 52
Devices cleared under the same product code (PKL) and FDA review panel - the closest regulatory comparables to K132809.
Single Use Hemoclip
K172762 · Zhejiang Chuangxiang Medical Technology Co., Ltd. · Mar 2018
Resolution Clip
K151802 · Boston Scientific Corporation · Aug 2015
Resolution Clip
K142973 · Boston Scientific Corporation · Dec 2014
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