FDA product code NWF: Drill, Battery Powered, Subungual Hematoma
NWF is the FDA product code for drill, battery powered, subungual hematoma. It is a Class I device, regulated under 21 CFR 878.4820 and reviewed by the General and Plastic Surgery panel. FDA has cleared 1 510(k) submission under NWF. The average 510(k) review took 31 days (median 31).
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).
Classification
| Field | Value |
|---|---|
| Device name | Drill, Battery Powered, Subungual Hematoma |
| Device class | Class I |
| Regulation | 21 CFR 878.4820 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every NWF clearance
Top NWF applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Path Scientific, LLC | 1 | 2005-10-31 |
Most recent NWF clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K052770 | Path Scientific, LLC | PATHFORMER | 2005-10-31 | 31 |
Recalls for NWF devices
openFDA lists no recalls for product code NWF.
Frequently asked questions
What is FDA product code NWF?
NWF is the FDA product code for drill, battery powered, subungual hematoma. It is a Class I device, regulated under 21 CFR 878.4820 and reviewed by the General and Plastic Surgery panel.
What device class is NWF?
Class I, regulation 21 CFR 878.4820. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code NWF?
Across 1 cleared submissions the average was 31 days from receipt to decision (median 31).
Which companies have the most NWF clearances?
Path Scientific, LLC (1).
Next steps
- Run an FDA pathway report with predicate devices for product code NWF
- Run a recall and safety report across every NWF manufacturer
- Watch product code NWF for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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