Ojemann Cortical Stimulator

• • Terminated Z-1030-2013 FDA Class II ·initiated 18 Mar 2013

  If the headphone jack is in use during a surgical procedure with the OCS2 and a non-intended voltage (such as static electricity) comes in contact with the outer case of the unit, that voltage could be transmitted to the patient and could be a potential source of injury.

510(k) Number

K924226 ↗

FDA Product Code

GYC

Device Class

Class II

Regulation

21 CFR Part 882.1310

Advisory Committee

Neurology

FDA Decision

SESE Substantially Equivalent

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• What is the Ojemann Cortical Stimulator used for?

  The Ojemann Cortical Stimulator is a cortical electrode device intended for neurological applications, as indicated by its classification under the Neurology specialty and its FDA 510(k) clearance for use as a portable system in such settings.

• How is the Ojemann Cortical Stimulator supplied and is it reusable?

  The device is supplied as a portable system for use in neurological applications; however, the provided data does not specify whether it is single-use or reusable, so reuse status cannot be determined from the available information.

• What regulatory pathway was used for the Ojemann Cortical Stimulator?

  The Ojemann Cortical Stimulator received FDA 510(k) clearance (K924226) on April 21, 1993, through a traditional review process, and was found to be substantially equivalent to a predicate device.