Cleared Traditional

K113771 - SIGNAL GEAR URETHRAL CATHETER ELECTRODE

K113771 is an FDA 510(k) clearance for SIGNAL GEAR URETHRAL CATHETER ELECTRODE, manufactured by Neurovision Medical Products, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FAP cleared through the Traditional 510(k) pathway after a 357-day FDA review.

K113771 · Neurovision Medical Products, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

FDA 510(k) Submission Details - K113771

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
226d slower than avg
Panel avg: 131d · This submission: 357d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FAP Device Classification - Class 2, Special Controls

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.

Regulatory Peers - FAP Cystometric Gas (carbon-dioxide) On Hydraulic Device

All 43
Devices cleared under the same product code (FAP) and FDA review panel - the closest regulatory comparables to K113771.
SINGLE CHANNEL UROLOGICAL PRESSURE GAUGE, DUAL CHANNEL UROLOGICAL PRESSURE GAUGE
K974775 · Airtronic Services, Inc. · Feb 1998
URODYNAMIC ANALYSIS MODULE
K963330 · Synectics Medical, Inc. · Apr 1997
RUSCH URODYNAMIC RECTAL BALLOON 2-WAY CATHETER
K962472 · Rusch Intl. · Aug 1996
SCHUSTER DISPOSABLE BALLOON PROBE
K931175 · Sandhill Scientific, Inc. · Apr 1994
UROLAB SPECTRUM
K931179 · Life-Tech Intl., Inc. · Nov 1993
URO-PRO 2000
K922476 · Fiberoptic Sensor Technlogies, Inc. · Jul 1993