← FDA Medical Device Classifications

Bougie, Urological

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

Classification

FDA Product Code

FAX

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

2

Registered establishments

57

Source

Authoritative

FDA Device Classification database

Machine

JSON-LD · Markdown