← FDA Medical Device Classifications

Instrument, Special Lens, For Endoscope

FEI · Class I — Low Risk (general controls) · Gastroenterology, Urology · 21 CFR 876.1500

Classification

FDA Product Code

FEI

Device class

Class I — Low Risk (general controls)

Regulation

21 CFR 876.1500

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

34

Source

Authoritative

FDA Device Classification database

Machine

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