Cleared Traditional

K151802 - Resolution Clip

K151802 is an FDA 510(k) clearance for Resolution Clip, manufactured by Boston Scientific Corporation. The device is a Class 2 Gastroenterology & Urology device with product code PKL cleared through the Traditional 510(k) pathway after a 35-day FDA review.

K151802 · Boston Scientific Corporation · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2015
Decision
35d
Days
Class 2
Risk

K151802 is an FDA 510(k) clearance for the Resolution 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 August 6, 2015 after a review of 35 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

FDA 510(k) Submission Details - K151802

510(k) Number K151802 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 02, 2015
Decision Date August 06, 2015
Days to Decision 35 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
96d faster than avg
Panel avg: 131d · This submission: 35d
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 61
Devices cleared under the same product code (PKL) and FDA review panel - the closest regulatory comparables to K151802.
FTRD System Set
K153550 · Ovesco Endoscopy AG · Oct 2016
Sterile Repositionable Hemostasis Clipping Device
K152001 · Micro-Tech (Nanjing) Co., Ltd. · Dec 2015
OTSC Proctology
K150067 · Ovesco Endoscopy AG · Sep 2015
Resolution Clip
K142973 · Boston Scientific Corporation · Dec 2014
INSTINCT ENDOSCOPIC HEMOCLIP
K132809 · Wilson-Cook Medical, Inc. · Oct 2013
SINGLE USE REPOSITIONABLE CLIP
K123601 · Olympus Medical Systems Corp. · Apr 2013