← FDA Medical Device Classifications

Dilator, Vaginal

HDX · Class II — Moderate Risk (510(k) clearance required) · Obstetrics/Gynecology · 21 CFR 884.3900

Classification

FDA Product Code

HDX

Device class

Class II — Moderate Risk (510(k) clearance required)

Regulation

21 CFR 884.3900

Review panel

OB

Medical specialty

Obstetrics/Gynecology

Submission type

1

GMP exempt

N

Life sustaining

N

Implant

N

Third-party review

Y

Market data

Cleared 510(k) submissions

9

Registered establishments

18

Source

Authoritative

FDA Device Classification database

Machine

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