510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K862331Substantially Equivalent

Fujitsu Malleable - Tip Brain Spatula

Downs Surgical, Ltd., Wilmington MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K862331 is the FDA 510(k) clearance record for FUJITSU MALLEABLE - TIP BRAIN SPATULA, a class I device, cleared for Downs Surgical , Ltd. on under FDA product code HAO (Instrument, Surgical, Non-Powered). FDA records list 60 510(k) clearances for Downs Surgical , Ltd., from to . As of , FDA records show no recalls naming K862331.

Clearance record

Decision date
Received
(12 days to decision)
Product code
HAO Instrument, Surgical, Non-Powered
Regulation
21 CFR 882.4535
Device class
Class I
Review panel
Neurology
Applicant
Downs Surgical , Ltd. 42 Industrial Way, Wilmington MA
Third party review
No

Clearances, product code HAO

Trailing 12 months

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

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