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Product codes
NWF
Product code NWF
Device name
Drill, Battery Powered, Subungual Hematoma
Medical specialty
General, Plastic Surgery
Device class
1
Regulation number
878.4820
Review panel
SU
Implant
N
Life sustaining/supporting
N
GMP exempt
N
Third party review
N
Summary malfunction reporting
Eligible
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).
Source
FDA openFDA device classification dataset
Related 510(k) Records
#
510(k), Device, Applicant table
510(k)
Device
Applicant
Decision date
K052770
PATHFORMER
Path Scientific, LLC
2005-10-31