← FDA Medical Device Classifications

Sterilizer, Ethylene-Oxide Gas

FLF · Class II — Moderate Risk (510(k) clearance required) · General Hospital · 21 CFR 880.6860

Classification

FDA Product Code

FLF

Device class

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

Regulation

21 CFR 880.6860

Review panel

HO

Medical specialty

General Hospital

Submission type

1

GMP exempt

N

Life sustaining

N

Implant

N

Third-party review

N

Market data

Cleared 510(k) submissions

26

Registered establishments

9

Source

Authoritative

FDA Device Classification database

Machine

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