510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K081591Substantially Equivalent

Neucodia

Verisci Corporation, Raritan NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K081591 is the FDA 510(k) clearance record for NEUCODIA, a class II device, cleared for Verisci Corporation on under FDA product code GWE (Stimulator, Photic, Evoked Response). FDA records list one 510(k) clearance for Verisci Corporation. As of , FDA records show no recalls naming K081591.

Clearance record

Decision date
Received
(343 days to decision)
Product code
GWE Stimulator, Photic, Evoked Response
Regulation
21 CFR 882.1890
Device class
Class II
Review panel
Neurology
Applicant
Verisci Corporation 106 Anderson St., Raritan NJ
510(k) summary
Summary PDF
Third party review
No

Clearances, product code GWE

Trailing 12 months

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

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