Cleared Traditional

TECHDEVICE GUIDEWIRE (K053028) - FDA 510(k) Clearance

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K053028 · Techdevice Corporation · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2006
Decision
96d
Days
Class 2
Risk

K053028 is an FDA 510(k) clearance for the TECHDEVICE GUIDEWIRE. Classified as Endoscopic Guidewire, Gastroenterology-urology (product code OCY), Class II - Special Controls.

Submitted by Techdevice Corporation (Watertown, US). The FDA issued a Cleared decision on January 31, 2006 after a review of 96 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 Techdevice Corporation devices

Submission Details

510(k) Number K053028 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 27, 2005
Decision Date January 31, 2006
Days to Decision 96 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
34d faster than avg
Panel avg: 130d · This submission: 96d
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 42
Devices cleared under the same product code (OCY) and FDA review panel - the closest regulatory comparables to K053028.
JAGWIRE HIGH PERFORMANCE GUIDWIRE
K141820 · Boston Scientific Corp · Oct 2014
BARD DIRECTOR GUIDEWIRE (000560)
K964780 · C.R. Bard, Inc. · Feb 1997
BARD TIGER GUIDEWIRE MODEL 000540
K962178 · C.R. Bard, Inc. · Oct 1996
AMPLATZ SUPER STIFF GUIDEWIRE
K944959 · Boston Scientific Corp · Nov 1994
MICROVASIVE PATHFINDER EXCHANGE GUIDEWIRE INSURG PATHFINDER GUIDEWIRE
K943737 · Boston Scientific Corp · Aug 1994
MICROVASIVE INSURG GEENEN CBD GUIDE WIRE
K931650 · Boston Scientific Corp · Jun 1993