Cleared Traditional

K113771 - SIGNAL GEAR URETHRAL CATHETER ELECTRODE (FDA 510(k) Clearance)

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

K113771 · Neurovision Medical Products, Inc. · Gastroenterology & Urology device
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Dec 2012
Decision
357d
Days
Class 2
Risk

K113771 is an FDA 510(k) clearance for the SIGNAL GEAR URETHRAL CATHETER ELECTRODE. Classified as Cystometric Gas (carbon-dioxide) On Hydraulic Device (product code FAP), Class II - Special Controls.

Submitted by Neurovision Medical Products, Inc. (Ventura, US). The FDA issued a Cleared decision on December 13, 2012 after a review of 357 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1620 - 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. Elevated predicate reliance profile. 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 Neurovision Medical Products, Inc. devices

Submission Details

510(k) Number K113771 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 22, 2011
Decision Date December 13, 2012
Days to Decision 357 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
227d slower than avg
Panel avg: 130d · This submission: 357d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FAP Cystometric Gas (carbon-dioxide) On Hydraulic Device
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1620
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.