Cleared Traditional

K133076 - NOVAGOLD HIGH PERFORMANCE GUIDEWIRE

K133076 is the FDA 510(k) clearance for NOVAGOLD HIGH PERFORMANCE GUIDEWIRE by Neometrics, Inc.. It is a Class 2 Gastroenterology & Urology device (product code OCY) cleared through the Traditional 510(k) pathway after a 143-day FDA review.

K133076 · Neometrics, Inc. · Gastroenterology & Urology device
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Feb 2014
Decision
143d
Days
Class 2
Risk

K133076 is an FDA 510(k) clearance for the NOVAGOLD HIGH PERFORMANCE GUIDEWIRE. Classified as Endoscopic Guidewire, Gastroenterology-urology (product code OCY), Class II - Special Controls.

Submitted by Neometrics, Inc. (Plymouth, US). The FDA issued a Cleared decision on February 20, 2014 after a review of 143 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 Neometrics, Inc. devices

Submission Details

510(k) Number K133076 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 2013
Decision Date February 20, 2014
Days to Decision 143 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
13d slower than avg
Panel avg: 130d · This submission: 143d
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 18
Devices cleared under the same product code (OCY) and FDA review panel - the closest regulatory comparables to K133076.
Orchestra Hydrophilic Guidewire standard angled, Orchestra Hydrophilic Guidewire straight stiff, Orchestra Hydrophilic Guidewire angled stiff,Orchestra Hydrophilic Guidewire standard straight, Orchestra Hydrophilic Guidewire straight stiff
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K122816 · Wilson-Cook Medical, Inc. · Oct 2012
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K082536 · Cook Urological, Inc. · Oct 2008