Cleared Traditional

K040137 - WILSON-COOK USW CAP AND WIRE LOCK

K040137 is the FDA 510(k) clearance for WILSON-COOK USW CAP AND WIRE LOCK by Wilson-Cook Medical, Inc.. It is a Class 2 Gastroenterology & Urology device (product code OCY) cleared through the Traditional 510(k) pathway after a 29-day FDA review.

K040137 · Wilson-Cook Medical, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2004
Decision
29d
Days
Class 2
Risk

K040137 is an FDA 510(k) clearance for the WILSON-COOK USW CAP AND WIRE LOCK. Classified as Endoscopic Guidewire, Gastroenterology-urology (product code OCY), Class II - Special Controls.

Submitted by Wilson-Cook Medical, Inc. (Winston-Salem, US). The FDA issued a Cleared decision on February 20, 2004 after a review of 29 days - a notably fast clearance cycle.

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: 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 Wilson-Cook Medical, Inc. devices

Submission Details

510(k) Number K040137 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 22, 2004
Decision Date February 20, 2004
Days to Decision 29 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
101d faster than avg
Panel avg: 130d · This submission: 29d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code OCY Endoscopic Guidewire, Gastroenterology-urology
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition To Provide Access To Gi Or Gu Tract For The Purpose Of Passing Or Exchanging Other Accessories.
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 - OCY Endoscopic Guidewire, Gastroenterology-urology

All 19
Devices cleared under the same product code (OCY) and FDA review panel - the closest regulatory comparables to K040137.
TAXI ENDOSCOPIC GUIDEWIRE
K081708 · Lake Region Mfg., Inc. · Aug 2008
NIPRO HYDROPHILIC GUIDEWIRE FOR UROLOGICAL & LAPAROSCOPIC USE
K060034 · Nipro Medical Corporation · Feb 2006
FX WIRE ADVANCED MEASUREMENT GUIDEWIRE
K050304 · Conmedcorp · Mar 2005
TRACER METRO SMART WIRE GUIDE
K033754 · Wilson-Cook Medical, Inc. · Dec 2003
CLIMBER - PARTIALLY COATED GUIDE WIRE FOR ENDOSCOPIC USE
K971937 · Terumo Medical Corp. · Aug 1997
BARD DIRECTOR GUIDEWIRE (000560)
K964780 · C.R. Bard, Inc. · Feb 1997