Cleared Special

K052051 - OMNI SPHINCTEROTOME

K052051 is the FDA 510(k) clearance for OMNI SPHINCTEROTOME by Wilson-Cook Medical, Inc.. It is a Class 2 Gastroenterology & Urology device (product code KNS) cleared through the Special 510(k) pathway after a 7-day FDA review.

K052051 · Wilson-Cook Medical, Inc. · Gastroenterology & Urology device
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Aug 2005
Decision
7d
Days
Class 2
Risk

K052051 is an FDA 510(k) clearance for the OMNI SPHINCTEROTOME. Classified as Unit, Electrosurgical, Endoscopic (with Or Without Accessories) (product code KNS), Class II - Special Controls.

Submitted by Wilson-Cook Medical, Inc. (Winston-Salem, US). The FDA issued a Cleared decision on August 5, 2005 after a review of 7 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.4300 - 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 K052051 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 29, 2005
Decision Date August 05, 2005
Days to Decision 7 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
123d faster than avg
Panel avg: 130d · This submission: 7d
Pathway characteristics
Modification to existing cleared device.

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
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