Not Cleared Post-NSE

DEN000006 - EROS-CLITORAL THERAPY DEVICE (CTD) (FDA 510(k) Clearance)

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

DEN000006 · Urometrics, Inc. · Obstetrics & Gynecology device
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Apr 2000
Decision
1d
Days
Class 2
Risk

DEN000006 is an FDA 510(k) submission (not cleared) for the EROS-CLITORAL THERAPY DEVICE (CTD). Classified as Device, Engorgement, Clitoral (product code NBV), Class II - Special Controls.

Submitted by Urometrics, Inc. (St. Paul, US). The FDA issued a Not Cleared (DENG) decision on April 28, 2000 after a review of 1 days.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.5970 - the FDA obstetrics and gynecology 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 Obstetrics & Gynecology review framework.

View all Urometrics, Inc. devices

Submission Details

510(k) Number DEN000006 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received April 27, 2000
Decision Date April 28, 2000
Days to Decision 1 days
Submission Type Post-NSE
Review Panel Obstetrics & Gynecology (OB)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
159d faster than avg
Panel avg: 160d · This submission: 1d
Pathway characteristics

Device Classification

Product Code NBV Device, Engorgement, Clitoral
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.5970
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 Obstetrics & Gynecology devices follow this clearance model.