OJEMANN CORTICAL STIMULATOR— 510(k) K924226

Substantially Equivalent

Radionics, Inc.

FDA 510(k) clearance K924226 for OJEMANN CORTICAL STIMULATOR, Substantially Equivalent on 1993-04-21. Applicant: Radionics, Inc.. Device class: 2.

Clearance details

Applicant: Radionics, Inc.
Product code: Code GYC
Device class: Class 2
Regulation: 21 CFR 882.1310
Advisory panel: Neurology
Date received: 1992-08-21
Decision date: 1993-04-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Burlington, MA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code GYC

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Recalls naming K924226

K-number listed on FDA's recall record

Z-1030-2013 — Integra Ojemann Cortical Stimulator; Product / Catalogue No: OCS2. Intended for intraoperative cortical stimulation mapping procedures.Class II·Terminated·Integra Burlington MA, Inc.·20130318

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K924226.

Data sourced from openFDA. This site is unofficial and independent of the FDA.