Product Classification

• Device: drills, burrs, trephines & accessories (simple, powered)
• Regulation Description: Powered simple cranial drills, burrs, trephines, and their accessories.
• Regulation Medical Specialty: Neurology
• Review Panel: Neurology
• Product Code: HBE
• Premarket Review: Office of Neurological and Physical Medicine Devices (OHT5); Neurosurgical, Neurointerventional and Neurodiagnostic Devices (DHT5A)
• Submission Type: 510(k)
• Regulation Number: 882.4310
• 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

• Eligible for 510(k) Third Party Review Program

Accredited Persons

• global quality and regulatory services
• regulatory technology services, llc
• third party review group, llc