Cleared Traditional

K172288 - Fusion OMNI Sphincterotome

K172288 is the FDA 510(k) clearance for Fusion OMNI Sphincterotome by Wilson-Cook Medical Inc./Cook Endoscopy. It is a Class 2 Gastroenterology & Urology device (product code KNS) cleared through the Traditional 510(k) pathway after a 260-day FDA review.

K172288 · Wilson-Cook Medical Inc./Cook Endoscopy · Gastroenterology & Urology device
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Apr 2018
Decision
260d
Days
Class 2
Risk

K172288 is an FDA 510(k) clearance for the Fusion OMNI Sphincterotome. Classified as Unit, Electrosurgical, Endoscopic (with Or Without Accessories) (product code KNS), Class II - Special Controls.

Submitted by Wilson-Cook Medical Inc./Cook Endoscopy (Winston-Salem, US). The FDA issued a Cleared decision on April 17, 2018 after a review of 260 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.4300 - 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 Wilson-Cook Medical Inc./Cook Endoscopy devices

Submission Details

510(k) Number K172288 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 31, 2017
Decision Date April 17, 2018
Days to Decision 260 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
130d slower than avg
Panel avg: 130d · This submission: 260d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KNS Unit, Electrosurgical, Endoscopic (with Or Without Accessories)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.4300
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 - KNS Unit, Electrosurgical, Endoscopic (with Or Without Accessories)

All 114
Devices cleared under the same product code (KNS) and FDA review panel - the closest regulatory comparables to K172288.
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