Drill, Battery Powered, Subungual Hematoma
The Battery-Powered Subungual Hematoma Drill is a surgical tool intended to cut a hole in finger or toenails to release fluid accumulated in the underlying nail bed, relieving pressure from subungual hematomas including black toe injuries. It provides a controlled, powered method for nail trephination without the need for heat-based devices. It is an FDA Class 1 device regulated under 21 CFR 878.4820 in the General and Plastic Surgery specialty, with product code NWF, and is exempt from premarket notification under submission type 4. It does not carry implant or life-sustaining support designations.
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Basic Information
- Product Code
- NWF
- Device Class
- FDA class 1
- Regulation Number
- 878.4820
- Medical Specialty
- General, Plastic Surgery
- Review Panel
- SU
- Submission Type
- 4
Device Characteristics
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).
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K052770 | PATHFORMER | Oct 31, 2005 | Substantially Equivalent | Path Scientific, LLC |
FEI Numbers
This FDA classification entry is associated with 5 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 5 registration numbers. Click on an entry to view related FDA registrations.