510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K952080Substantially Equivalent

Clarity System II

Sonamed Corp., Weston MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K952080 is the FDA 510(k) clearance record for CLARITY SYSTEM II, a class II device, cleared for Sonamed Corp. on under FDA product code GWJ (Stimulator, Auditory, Evoked Response). FDA records list one 510(k) clearance for Sonamed Corp. As of , FDA records show one recall naming K952080.

Clearance record

Decision date
Received
(139 days to decision)
Product code
GWJ Stimulator, Auditory, Evoked Response
Regulation
21 CFR 882.1900
Device class
Class II
Review panel
Neurology
Applicant
Sonamed Corp. 306 Merriam St., Weston MA
510(k) summary
Statement
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