510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K810539Substantially Equivalent

Model S10ctcm Auditory Stimulator

Grass Instrument Co., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K810539 is the FDA 510(k) clearance record for MODEL S10CTCM AUDITORY STIMULATOR, a class II device, cleared for Grass Instrument Co. on under FDA product code GWJ (Stimulator, Auditory, Evoked Response). FDA records list 6 510(k) clearances for Grass Instrument Co., from to . As of , FDA records show no recalls naming K810539.

Clearance record

Decision date
Received
(18 days to decision)
Product code
GWJ Stimulator, Auditory, Evoked Response
Regulation
21 CFR 882.1900
Device class
Class II
Review panel
Neurology
Applicant
Grass Instrument Co. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code GWJ

Trailing 12 months

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

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