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U.S. Department of Health and Human Services

Product Classification

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Device neurosurgical nerve locator
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
Product CodePDQ
Premarket Review 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
Eligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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