510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K052770Substantially Equivalent

Pathformer

Path Scientific, Chevy Chase MD / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K052770 is the FDA 510(k) clearance record for PATHFORMER, a class I device, cleared for Path Scientific, LLC on under FDA product code NWF (Drill, Battery Powered, Subungual Hematoma). FDA's definition for product code NWF reads: "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)". FDA records list one 510(k) clearance for Path Scientific, LLC. As of , FDA records show no recalls naming K052770.

Clearance record

Decision date
Received
(31 days to decision)
Product code
NWF Drill, Battery Powered, Subungual Hematoma
Regulation
21 CFR 878.4820
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Path Scientific, LLC 5600 Wisconsin Ave., # 509, Chevy Chase MD
510(k) summary
Summary PDF
Third party review
No

Clearances, product code NWF

Trailing 12 months

FDA records hold no clearances under product code NWF in the trailing twelve months.

FDA records show no clearances under product code NWF in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code NWF, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260