Identification. A nasopharyngeal electrode is an electrode which is temporarily placed in the nasopharyngeal region for the purpose of recording electrical activity.

Classification. Class II (performance standards).

Identification. A needle electrode is a device which is placed subcutaneously to stimulate or to record electrical signals.

Classification. Class II (performance standards).

Identification. A nerve conduction velocity measurement device is a device which measures nerve conduction time by applying a stimulus, usually to a patient's peripheral nerve. This device includes the stimulator and the electronic processing equipment for measuring and displaying the nerve conduction time.

Classification. Class II (performance standards).

Identification. A nerve cuff is a tubular silicone rubber sheath used to encase a nerve for aid in repairing the nerve (e.g., to prevent ingrowth of scar tissue) and for capping the end of the nerve to prevent the formation of neuroma (tumors).

Classification. Class II (performance standards).

Identification. A neurological endoscope is an instrument with a light source used to view the inside of the ventricles of the brain.

Classification. Class II (performance standards).

Identification. A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.

Classification. Class II (performance standards).

Identification. A microsurgical instrument is a nonpowered surgical instrument used in neurological microsurgery procedures.

Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in 882.9.