Cleared Traditional

K102764 - RESOLUTION II CLIP

K102764 is the FDA 510(k) clearance for RESOLUTION II CLIP by Boston Scientific Corporation. It is a Class 2 Gastroenterology & Urology device (product code PKL) cleared through the Traditional 510(k) pathway after a 89-day FDA review.

K102764 · Boston Scientific Corporation · Gastroenterology & Urology device
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Dec 2010
Decision
89d
Days
Class 2
Risk

K102764 is an FDA 510(k) clearance for the RESOLUTION II CLIP. Classified as Hemostatic Metal Clip For The Gi Tract (product code PKL), Class II - Special Controls.

Submitted by Boston Scientific Corporation (Marlboro, US). The FDA issued a Cleared decision on December 22, 2010 after a review of 89 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Boston Scientific Corporation devices

Submission Details

510(k) Number K102764 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 24, 2010
Decision Date December 22, 2010
Days to Decision 89 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
41d faster than avg
Panel avg: 130d · This submission: 89d
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 Peers - PKL Hemostatic Metal Clip For The Gi Tract

All 54
Devices cleared under the same product code (PKL) and FDA review panel - the closest regulatory comparables to K102764.
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
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