NWF — Drill, Battery Powered, Subungual Hematoma Class I

FDA Device Classification

FDA product code NWF covers "Drill, Battery Powered, Subungual Hematoma", a Class I medical device regulated under 21 CFR 878.4820. Submissions are reviewed by the General, Plastic Surgery panel. At least 1 recent 510(k) clearance has been granted under this product code.

Classification Details

Product Code
NWF
Device Class
Class I
Regulation Number
878.4820
Submission Type
Review Panel
SU
Medical Specialty
General, Plastic Surgery
Implant
No

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).

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K052770path scientificPATHFORMEROctober 31, 2005