← FDA Medical Device Classifications

Leukotome

GXE · Class I — Low Risk (general controls) · Neurology · 21 CFR 882.4600

Classification

FDA Product Code

GXE

Device class

Class I — Low Risk (general controls)

Regulation

21 CFR 882.4600

Review panel

NE

Medical specialty

Neurology

Submission type

4

GMP exempt

N

Life sustaining

N

Implant

N

Third-party review

N

Market data

Cleared 510(k) submissions

1

Registered establishments

0

Source

Authoritative

FDA Device Classification database

Machine

JSON-LD · Markdown