NWF · Class I — Low Risk (general controls) · General, Plastic Surgery · 21 CFR 878.4820
Classification
FDA Product Code
NWF
Device class
Class I — Low Risk (general controls)
Regulation
21 CFR 878.4820
Review panel
SU
Medical specialty
General, Plastic Surgery
Submission type
4
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N
Definition
Intended to cut a hole in finger and toe nails to release fluid accumulated in the underlying nail bed. Indicated to relieve pressure from subungual hematomas (including black toe).