Cleared Traditional

K973205 - WILSON-COOK STRICTURE MEASURING CATHETER

K973205 is the FDA 510(k) clearance for WILSON-COOK STRICTURE MEASURING CATHETER by Wilson-Cook Medical, Inc.. It is a Class 2 Gastroenterology & Urology device (product code ODD) cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K973205 · Wilson-Cook Medical, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1997
Decision
90d
Days
Class 2
Risk

K973205 is an FDA 510(k) clearance for the WILSON-COOK STRICTURE MEASURING CATHETER. Classified as Endoscopic Retrograde Cholangiopancreatography (ercp) Cannula (product code ODD), Class II - Special Controls.

Submitted by Wilson-Cook Medical, Inc. (Winston-Salem, US). The FDA issued a Cleared decision on November 24, 1997 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1500 - 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. devices

Submission Details

510(k) Number K973205 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 26, 1997
Decision Date November 24, 1997
Days to Decision 90 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
40d faster than avg
Panel avg: 130d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code ODD Endoscopic Retrograde Cholangiopancreatography (ercp) Cannula
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition To Identify Stones, Tumors, Or Narrowing In The Biliary Tree.
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 - ODD Endoscopic Retrograde Cholangiopancreatography (ercp) Cannula

All 10
Devices cleared under the same product code (ODD) and FDA review panel - the closest regulatory comparables to K973205.
Classic ERCP Catheter and Huibregtse-Katon ERCP Catheter and Huibregtse-Katon Angled, Glo-Tip ERCP Catheter, Glo-Tip II Double Lumen ERCP Catheter & w/ Radiopaque Bands, Fusion ERCP Catheter with DomeTip and Fusion OMNI ERCP Catheter with DomeTip, Haber RAMP Catheter, Soehendra Universal Catheter
K171989 · Wilson-Cook Medical, Inc. · Mar 2018
BIOSHIELD-ERCP BIOPSY VALVE, MODEL 00711138
K070420 · United States Endoscopy Group, Inc. · Mar 2007
ALIEN RX MICRO CANNULA, MODEL 4530
K010993 · Boston Scientific Corp · Apr 2001
ERCP CANNULA
K963051 · United States Endoscopy Group, Inc. · Mar 1997
BARD BILISYSTEM ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) CANNULA
K950700 · C.R. Bard, Inc. · Apr 1995
OLYMPUS PR-23Q DISPOSABLE CANNULA (BALL TIP)
K950729 · Olympus America, Inc. · Mar 1995