Cleared Traditional

K123601 - SINGLE USE REPOSITIONABLE CLIP

K123601 is the FDA 510(k) clearance for SINGLE USE REPOSITIONABLE CLIP by Olympus Medical Systems Corp.. It is a Class 2 Gastroenterology & Urology device (product code PKL) cleared through the Traditional 510(k) pathway after a 159-day FDA review.

K123601 · Olympus Medical Systems Corp. · Gastroenterology & Urology device
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Apr 2013
Decision
159d
Days
Class 2
Risk

K123601 is an FDA 510(k) clearance for the SINGLE USE REPOSITIONABLE CLIP. Classified as Hemostatic Metal Clip For The Gi Tract (product code PKL), Class II - Special Controls.

Submitted by Olympus Medical Systems Corp. (Center Valley, US). The FDA issued a Cleared decision on April 29, 2013 after a review of 159 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 Olympus Medical Systems Corp. devices

Submission Details

510(k) Number K123601 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 21, 2012
Decision Date April 29, 2013
Days to Decision 159 days
Submission Type Traditional
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
29d slower than avg
Panel avg: 130d · This submission: 159d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 Consultant

Olympus Medical Systems Corporation
Steven L Keenan

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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 K123601.
Resolution Clip
K151802 · Boston Scientific Corporation · Aug 2015
Resolution Clip
K142973 · Boston Scientific Corporation · Dec 2014
INSTINCT ENDOSCOPIC HEMOCLIP
K132809 · Wilson-Cook Medical, Inc. · Oct 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