Device |
optical neurosurgical nerve locator |
Regulation Description |
Surgical nerve stimulator/locator. |
Definition |
To locate or monitor function of spinal nerve roots or peripheral nerves during neurosurgery. |
Physical State |
A user interface/control unit; and handpiece unit with a light source and an optical sensor. |
Technical Method |
Emits white light, collects information on the color reflected, and informs users of changes from baseline. |
Target Area |
Spinal nerve roots or peripheral nerves |
Regulation Medical Specialty |
Ear Nose & Throat |
Review Panel |
Neurology |
Product Code | QWP |
Premarket Review |
Office of Neurological and Physical Medicine Devices
(OHT5)
Neurosurgical, Neurointerventional and Neurodiagnostic Devices
(DHT5A)
|
Submission Type |
510(k)
|
Regulation Number |
874.1820
|
Device Class |
2
|
Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
GMP Exempt? |
No
|
Summary Malfunction Reporting |
Ineligible |
Implanted Device? |
No
|
Life-Sustain/Support Device? |
No
|
Third Party Review |
Not Third Party Eligible |