Cleared Special

K033754 - TRACER METRO SMART WIRE GUIDE

K033754 is an FDA 510(k) clearance for TRACER METRO SMART WIRE GUIDE, manufactured by Wilson-Cook Medical, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code OCY cleared through the Special 510(k) pathway after a 29-day FDA review.

K033754 · Wilson-Cook Medical, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
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Dec 2003
Decision
29d
Days
Class 2
Risk

K033754 is an FDA 510(k) clearance for the TRACER METRO SMART WIRE GUIDE. 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 December 30, 2003 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. 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

FDA 510(k) Submission Details - K033754

510(k) Number K033754 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 01, 2003
Decision Date December 30, 2003
Days to Decision 29 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
102d faster than avg
Panel avg: 131d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

OCY Device Classification - Class 2, Special Controls

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 38
Devices cleared under the same product code (OCY) and FDA review panel - the closest regulatory comparables to K033754.
TECHDEVICE GUIDEWIRE
K053028 · Techdevice Corporation · Jan 2006
FX WIRE ADVANCED MEASUREMENT GUIDEWIRE
K050304 · Conmedcorp · Mar 2005
WILSON-COOK USW CAP AND WIRE LOCK
K040137 · Wilson-Cook Medical, Inc. · Feb 2004
DISPOSABLE GUIDEWIRE, MODELS G-205-3545S & G-205-3545A
K021179 · Olympus Optical Co., Ltd. · Jul 2002
FLEXFINDER GUIDE WIRE(REGULAR SHAFT/STIFF SHAFT) MARKED INK BANDS, FLEXFINDER GUIDE WIRE (REGULAR SHAFT/STIFF SHAFT) NO
K990765 · Flexmedics · Mar 1999
CLIMBER - PARTIALLY COATED GUIDE WIRE FOR ENDOSCOPIC USE
K971937 · Terumo Medical Corp. · Aug 1997