← FDA Medical Device Classifications

Insufflator, Vaginal

HEC · Class I — Low Risk (general controls) · Obstetrics/Gynecology · 21 CFR 884.5920

Classification

FDA Product Code

HEC

Device class

Class I — Low Risk (general controls)

Regulation

21 CFR 884.5920

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

0

Registered establishments

4

Source

Authoritative

FDA Device Classification database

Machine

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