510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K082250Substantially Equivalent

Auragen Cortical Surface Electrodes

Integra NeuroSciences, Planisboro NJ / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K082250 is the FDA 510(k) clearance record for AURAGEN CORTICAL SURFACE ELECTRODES, a class II device, cleared for Integra Neurosciences on under FDA product code GYC (Electrode, Cortical). FDA records list 9 510(k) clearances for Integra Neurosciences, from to . As of , FDA records show no recalls naming K082250.

Clearance record

Decision date
Received
(63 days to decision)
Product code
GYC Electrode, Cortical
Regulation
21 CFR 882.1310
Device class
Class II
Review panel
Neurology
Applicant
Integra Neurosciences 311 Enterprise Dr., Planisboro NJ
510(k) summary
Summary PDF
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