510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K193033Substantially Equivalent

GSI Audera Pro

Grason-Stadler, Inc., Eden Prairie MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K193033 is the FDA 510(k) clearance record for GSI Audera Pro, a class II device, cleared for Grason Stadler on under FDA product code GWJ (Stimulator, Auditory, Evoked Response). FDA records list 17 510(k) clearances for Grason Stadler, from to . As of , FDA records show no recalls naming K193033.

Clearance record

Decision date
Received
(176 days to decision)
Product code
GWJ Stimulator, Auditory, Evoked Response
Regulation
21 CFR 882.1900
Device class
Class II
Review panel
Neurology
Applicant
Grason Stadler 10395 W. 70th St., Eden Prairie MN
510(k) summary
Summary PDF
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