← FDA Medical Device Classifications

Douche Apparatus, Vaginal, Therapeutic

HED · Class I — Low Risk (general controls) · Obstetrics/Gynecology · 21 CFR 884.5900

Classification

FDA Product Code

HED

Device class

Class I — Low Risk (general controls)

Regulation

21 CFR 884.5900

Review panel

OB

Medical specialty

Obstetrics/Gynecology

Submission type

4

GMP exempt

N

Life sustaining

N

Implant

N

Third-party review

N

Market data

Cleared 510(k) submissions

12

Registered establishments

43

Source

Authoritative

FDA Device Classification database

Machine

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