meddevicedb.com FDA Device Reference

EROS-CLITORAL THERAPY DEVICE (CTD)

DEN000006 Class II Post-NSE
Decision Date
2000-04-28
Sponsor / Applicant
Urometrics, Inc.

Technical Specification

510(k) Submission ID DEN000006
Product Code NBV
Medical Specialty / Panel Obstetrics/Gynecology
Regulation Citation 21 CFR 884.5970
Decision Date 2000-04-28
Clearance Pathway Post-NSE

Official Documentation

No FDA summary/statement PDF is linked for this clearance in the current dataset. Consult the product code and regulation citation above to locate predicate documentation.

Clearance Summary

EROS-CLITORAL THERAPY DEVICE (CTD) received FDA 510(k) clearance under submission number DEN000006, sponsored by Urometrics, Inc.. The device was reviewed via the Post-NSE premarket notification pathway and assigned to the Obstetrics/Gynecology review panel. The statutory decision date of record is 2000-04-28.

Classification & Regulation

This clearance is catalogued under FDA product code NBV and 21 CFR 884.5970, within the Obstetrics/Gynecology review panel as a Class II device.