510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K941285Substantially Equivalent

Arthrex Graft Harvesting Kit

Arthrex GmbH, Naples FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K941285 is the FDA 510(k) clearance record for ARTHREX GRAFT HARVESTING KIT, a class I device, cleared for Arthrex, Inc. on under FDA product code KIJ (Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment). FDA records list 352 510(k) clearances for Arthrex, Inc., from to . As of , FDA records show no recalls naming K941285.

Clearance record

Decision date
Received
(242 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
Arthrex, Inc. 3050 N. Horseshoe Dr., Naples FL
510(k) summary
Statement
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