Cleared Traditional

K072354 - GUIDEWIRE

K072354 is an FDA 510(k) clearance for GUIDEWIRE, manufactured by Accellent, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code OCY cleared through the Traditional 510(k) pathway after a 107-day FDA review.

K072354 · Accellent, Inc. · Gastroenterology & Urology device
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Optimized for regulatory review, auditing and printing
Dec 2007
Decision
107d
Days
Class 2
Risk

K072354 is an FDA 510(k) clearance for the GUIDEWIRE, MODEL G-V220-3527S AND OTHERS. Classified as Endoscopic Guidewire, Gastroenterology-urology (product code OCY), Class II - Special Controls.

Submitted by Accellent, Inc. (Wilmington, US). The FDA issued a Cleared decision on December 7, 2007 after a review of 107 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 Accellent, Inc. devices

FDA 510(k) Submission Details - K072354

510(k) Number K072354 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 22, 2007
Decision Date December 07, 2007
Days to Decision 107 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
23d faster than avg
Panel avg: 130d · This submission: 107d
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 K072354.
AXCESS SOFT TIP WIRE GUIDE
K122816 · Wilson-Cook Medical, Inc. · Oct 2012
COOK WIRE GUIDES
K082536 · Cook Urological, Inc. · Oct 2008
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
WILSON-COOK USW CAP AND WIRE LOCK
K040137 · Wilson-Cook Medical, Inc. · Feb 2004