← FDA Medical Device Classifications

Filiform And Filiform Follower

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

Classification

FDA Product Code
FBW
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
1
Registered establishments
12

Source

Authoritative
FDA Device Classification database
Machine
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