FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

FDA 510(k) Search

K Number

DEN000006

Device Name

EROS-CLITORAL THERAPY DEVICE (CTD)

Manufacturer

UROMETRICS, INC.

Date Cleared

2000-04-28

(1 days)

Product Code

NBV

Regulation Number

884.5970

Intended Use

Device Description

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

N/A

Reference Devices

N/A

AI/ML (Artificial Intelligence / Machine Learning)

N/A

Therapeutic

N/A

Diagnostic

N/A

SaMD (Software as a Medical Device)

N/A

IVD (In Vitro Diagnostic)

N/A

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

N/A

Regulation Number and Section

§ 884.5970 Clitoral engorgement device.

(a)
Identification. A clitoral engorgement device is designed to apply a vacuum to the clitoris. It is intended for use in the treatment of female sexual arousal disorder.(b)
Classification. Class II (special controls). The special control is a guidance document entitled: “Guidance for Industry and FDA Reviewers: Class II Special Controls Guidance Document for Clitoral Engorgement Devices.”

Summary

N/A