510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K923330Substantially Equivalent

The Western Cortical Electrode Array

University Hospital (London) Development Corp., London Ontario N6a 5n6, CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K923330 is the FDA 510(k) clearance record for THE WESTERN CORTICAL ELECTRODE ARRAY, a class II device, cleared for University Hospital (London) Development Corp. on under FDA product code GYC (Electrode, Cortical). FDA records list one 510(k) clearance for University Hospital (London) Development Corp. As of , FDA records show no recalls naming K923330.

Clearance record

Decision date
Received
(490 days to decision)
Product code
GYC Electrode, Cortical
Regulation
21 CFR 882.1310
Device class
Class II
Review panel
Neurology
Applicant
University Hospital (London) Development Corp. 150 Dufferin Ave., London Ontario N6a 5n6, CA
510(k) summary
Statement
Third party review
No

Clearances, product code GYC

Trailing 12 months

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

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