Not Cleared Post-NSE

DEN000002 - UROSURGE PERCUTANEOUS SANS (STOLLER AFFERENT NERVE STIMULATOR) DEVICE (FDA 510(k) Clearance)

Class II Gastroenterology & Urology device cleared through the Post-NSE 510(k) pathway - typically does not require clinical trials.

DEN000002 · Urosurge, Inc. · Gastroenterology & Urology device
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Feb 2000
Decision
13d
Days
Class 2
Risk

DEN000002 is an FDA 510(k) submission (not cleared) for the UROSURGE PERCUTANEOUS SANS (STOLLER AFFERENT NERVE STIMULATOR) DEVICE. Classified as Stimulator, Peripheral Nerve, Non-implanted, For Urinary Incontinence (product code NAM), Class II - Special Controls.

Submitted by Urosurge, Inc. (Coralville, US). The FDA issued a Not Cleared (DENG) decision on February 9, 2000 after a review of 13 days.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5310 - the FDA gastroenterology and urology device framework. The Traditional 510(k) pathway requires demonstration of substantial equivalence to a legally marketed predicate device - a standard the FDA determined was not met in this submission.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. This submission did not achieve clearance, indicating the FDA determined the device lacked sufficient predicate equivalence under the Gastroenterology & Urology review framework.

View all Urosurge, Inc. devices

Submission Details

510(k) Number DEN000002 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received January 27, 2000
Decision Date February 09, 2000
Days to Decision 13 days
Submission Type Post-NSE
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
117d faster than avg
Panel avg: 130d · This submission: 13d
Pathway characteristics

Device Classification

Product Code NAM Stimulator, Peripheral Nerve, Non-implanted, For Urinary Incontinence
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5310
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.