Cleared Traditional

K011759 - RADIUS NEXT GENERATION GUIDEWIRE

K011759 is an FDA 510(k) clearance for RADIUS NEXT GENERATION GUIDEWIRE, manufactured by Radius Medical Technologies, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code OCY cleared through the Traditional 510(k) pathway after a 78-day FDA review.

K011759 · Radius Medical Technologies, Inc. · Gastroenterology & Urology device
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Aug 2001
Decision
78d
Days
Class 2
Risk

K011759 is an FDA 510(k) clearance for the RADIUS NEXT GENERATION GUIDEWIRE. Classified as Endoscopic Guidewire, Gastroenterology-urology (product code OCY), Class II - Special Controls.

Submitted by Radius Medical Technologies, Inc. (Maynard, US). The FDA issued a Cleared decision on August 23, 2001 after a review of 78 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 Radius Medical Technologies, Inc. devices

FDA 510(k) Submission Details - K011759

510(k) Number K011759 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 06, 2001
Decision Date August 23, 2001
Days to Decision 78 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
52d faster than avg
Panel avg: 130d · This submission: 78d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 21
Devices cleared under the same product code (OCY) and FDA review panel - the closest regulatory comparables to K011759.
FX WIRE ADVANCED MEASUREMENT GUIDEWIRE
K050304 · Conmedcorp · Mar 2005
WILSON-COOK USW CAP AND WIRE LOCK
K040137 · Wilson-Cook Medical, Inc. · Feb 2004
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
BARD TIGER GUIDEWIRE MODEL 000540
K962178 · C.R. Bard, Inc. · Oct 1996