510(k) K052770
K052770 is an FDA 510(k) premarket notification submitted by Path Scientific, LLC for the device "PATHFORMER". The FDA issued a decision of Substantially Equivalent on October 31, 2005. The device falls under product code NWF (Drill, Battery Powered, Subungual Hematoma), a Class I device regulated under 21 CFR 878.4820.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 31, 2005
- Date Received
- September 30, 2005
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Drill, Battery Powered, Subungual Hematoma
- Device Class
- Class I
- Regulation Number
- 878.4820
- Review Panel
- SU
- Submission Type
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).