510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K820351Substantially Equivalent

Cast Cutter/cast Saw/instrument

Black & Decker(Tm), Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K820351 is the FDA 510(k) clearance record for CAST CUTTER/CAST SAW/INSTRUMENT, a class I device, cleared for Black & Decker(Tm) on under FDA product code LGH (Instrument, Cast Removal, Ac-Powered). FDA records list 11 510(k) clearances for Black & Decker(Tm), from to . As of , FDA records show no recalls naming K820351.

Clearance record

Decision date
Received
(22 days to decision)
Product code
LGH Instrument, Cast Removal, Ac-Powered
Regulation
21 CFR 888.5960
Device class
Class I
Review panel
Orthopedic
Applicant
Black & Decker(Tm) 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code LGH

Trailing 12 months

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

FDA records show no clearances under product code LGH in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code LGH, 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