Not Cleared Post-NSE

DEN000006 - EROS-CLITORAL THERAPY DEVICE (CTD)

DEN000006 is an FDA 510(k) submission for EROS-CLITORAL THERAPY DEVICE (CTD), manufactured by Urometrics, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code NBV cleared through the Post-NSE 510(k) pathway after a 1-day FDA review.

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

FDA 510(k) Submission Details - DEN000006

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

NBV Device Classification - Class 2, Special Controls

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.