510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K800312Substantially Equivalent

150 Driver/reamer

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

K800312 is the FDA 510(k) clearance record for 150 DRIVER/REAMER, a class I device, cleared for Black & Decker(Tm) on under FDA product code KIJ (Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment). FDA records list 11 510(k) clearances for Black & Decker(Tm), from to . As of , FDA records show no recalls naming K800312.

Clearance record

Decision date
Received
(10 days to decision)
Product code
KIJ Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment
Regulation
21 CFR 878.4820
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Black & Decker(Tm) 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code KIJ

Trailing 12 months

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

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