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U.S. Department of Health and Human Services

Product Classification

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Device 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; 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 Office of Device Evaluation (ODE)
Division of Neurological and Physical Medicine Devices (DNPMD)
Neurodiagnostic and Neurosurgical Devices Branch (NDNB)
Submission Type 510(k)
Regulation Number 874.1820
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible