← FDA Medical Device Classifications

Sound, Urethral, Metal Or Plastic

FBX · Class I — Low Risk (general controls) · Gastroenterology, Urology · 21 CFR 876.5520

Classification

FDA Product Code

FBX

Device class

Class I — Low Risk (general controls)

Regulation

21 CFR 876.5520

Review panel

GU

Medical specialty

Gastroenterology, Urology

Submission type

4

GMP exempt

N

Life sustaining

N

Implant

N

Third-party review

N

Market data

Cleared 510(k) submissions

1

Registered establishments

53

Source

Authoritative

FDA Device Classification database

Machine

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