← FDA Medical Device Classifications

Counter, Sponge, Surgical

LWH · Class I — Low Risk (general controls) · General Hospital · 21 CFR 880.2740

Classification

FDA Product Code

LWH

Device class

Class I — Low Risk (general controls)

Regulation

21 CFR 880.2740

Review panel

SU

Medical specialty

General Hospital

Submission type

4

GMP exempt

N

Life sustaining

N

Implant

N

Third-party review

N

Market data

Cleared 510(k) submissions

15

Registered establishments

50

Source

Authoritative

FDA Device Classification database

Machine

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