DeviceClearance

Product code NWF— General, Plastic Surgery

PATHFORMER

Classification name
Drill, Battery Powered, Subungual Hematoma
Device class
Class 1
Regulation
21 CFR 878.4820
Advisory panel
General, Plastic Surgery
Total cleared
1
First cleared
Most recent

FDA classification 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).”

— U.S. Food and Drug Administration, device classification record for product code NWF under 21 CFR 878.4820, via openFDA

Market context for product code NWF

FDA has cleared 1 device under product code NWF, all in 2005, filed by 1 applicant company. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.

Top applicants under product code NWF

Recent clearances under product code NWF

Data sourced from openFDA. This site is unofficial and independent of the FDA.