510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K924226Substantially Equivalent

Ojemann Cortical Stimulator

Radionics, Inc., Burlington MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K924226 is the FDA 510(k) clearance record for OJEMANN CORTICAL STIMULATOR, a class II device, cleared for Radionics, Inc. on under FDA product code GYC (Electrode, Cortical). FDA records list 57 510(k) clearances for Radionics, Inc., from to . As of , FDA records show one recall naming K924226.

Clearance record

Decision date
Received
(243 days to decision)
Product code
GYC Electrode, Cortical
Regulation
21 CFR 882.1310
Device class
Class II
Review panel
Neurology
Applicant
Radionics, Inc. P.O. Box 438, Burlington MA
510(k) summary
Summary
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