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U.S. Department of Health and Human Services

Product Classification
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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 CodeQWP
Premarket Review Neurosurgical, Neurointerventional and Neurodiagnostic Devices (DHT5A)
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
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