Last synced on 2 December 2022 at 11:04 pm

Neurosurgical Nerve Locator

Page Type
Product Code
Definition
To locate or monitor function of spinal nerve roots or peripheral nerves during neurosurgery.
Physical State
A user interface/control unit; handpiece with tip to deliver the electric current; and a separate monitoring electrode if detection is not built in the same tip.
Technical Method
Sends out electrical current, monitors for this current, and informs user of a change from baseline.
Target Area
Spinal nerve roots or peripheral nerves
Regulation Medical Specialty
Ear, Nose, Throat
Review Panel
Neurology
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
874.1820
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 874.1820 Surgical nerve stimulator/locator

§ 874.1820 Surgical nerve stimulator/locator.

(a) Identification. A surgical nerve stimulator/locator is a device that is intended to provide electrical stimulation to the body to locate and identify nerves and to test their excitability.

(b) Classification. Class II.

Neurosurgical Nerve Locator

Page Type
Product Code
Definition
To locate or monitor function of spinal nerve roots or peripheral nerves during neurosurgery.
Physical State
A user interface/control unit; handpiece with tip to deliver the electric current; and a separate monitoring electrode if detection is not built in the same tip.
Technical Method
Sends out electrical current, monitors for this current, and informs user of a change from baseline.
Target Area
Spinal nerve roots or peripheral nerves
Regulation Medical Specialty
Ear, Nose, Throat
Review Panel
Neurology
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
874.1820
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 874.1820 Surgical nerve stimulator/locator

§ 874.1820 Surgical nerve stimulator/locator.

(a) Identification. A surgical nerve stimulator/locator is a device that is intended to provide electrical stimulation to the body to locate and identify nerves and to test their excitability.

(b) Classification. Class II.