BEUDAMED
    Product Code: HBC FDA class 2 21 CFR 882.4360

    Motor, Drill, Electric

    Neurology

    The Electric Drill Motor is an electrically powered drive unit used to operate neurosurgical drill bits, burrs, and trephines during cranial bone procedures, providing controlled rotational speed for bone penetration with reduced risk of soft tissue injury. It is classified as a Class 2 device (moderate risk), requiring 510(k) premarket notification. The product code is HBC under regulation 21 CFR 882.4360 in the Neurology specialty. It is eligible for third-party 510(k) review.

    View on FDA
    510(k)s
    26
    FEI Numbers
    49
    Registration Numbers
    49
    Unique Applicants
    15
    Years Active
    43

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    Basic Information

    Product Code
    HBC
    Device Class
    FDA class 2
    Regulation Number
    882.4360
    Medical Specialty
    Neurology
    Review Panel
    NE
    Submission Type
    1

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✓
    Third Party
    —
    Summary Malfunction Reporting

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 26 510(k) clearances via K numbers.

    K Number Device Name
    K233153 Traus SSG10 Surgical System
    K232938 Traus SSG30 Surgical System
    K213697 ORiGO System
    K220485 Wireless Hand Control, EG1A (WIRELESS-HC), Receiver for Wireless Hand Control, EG1A (RECEIVER-HC)
    K193630 hekaDrill
    K183515 MR8 Drill System, Midas Rex MR8 ClearView Tools
    K173066 OSSEODUO Shaver and Drill System
    K170312 IPC systems, Legend EHS handpieces and Legend Stylus Touch handpiece, Microsaw handpieces,Triton electric high torque handpiece, Attachments and surgical dissecting tools
    K163565 MR8 Drill System
    K152960 ELAN 4 Motor System
    K133604 ANSPACH EG1 HIGH SPEED SYSTEM, G1 ATTACHMENTS
    K132264 PRIMADO2 TOTAL SURGICAL SYSTEM
    K130497 D4000 DRIVE SYSTEM; D4000A DRIVE SYSTEM WITH IRRIGATION
    K083112 PRIMADO
    K080444 CONMED LINVATEC OSPREY DRILL SYSTEM
    K060260 MICROPOWER HAND PIECE HIGH SPEED DRILL
    K053526 MICROSPEED UNI MOTOR SYSTEM
    K022986 THE BIOPLATE BATTERY POWERED DRILL
    K012457 SODEM HIGH SPEED SYSTEM (ELECTRIC) (NEURO/SPINE SURGERY)
    K012453 SODEM HIGH SPEED SYSTEM (ELECTRIC) (GENERAL ORTHOPEDICS & PLASTIC SURGERY)
    K011444 ANSPACH EMAX DRILL SYSTEM
    K003612 MICROSPEED EC MOTORSYSTEM GD650/GD653
    K002523 ADVANTAGE DRIVE SYSTEM
    K972857 SERVOTRONIC EC100 SYSTEM
    K862989 SURGICAL DRILL (ELECTRIC) INCLUDING HANDPIECE
    K812436 450/800 DRILL

    FEI Numbers

    This FDA classification entry is associated with 49 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 49 registration numbers. Click on an entry to view related FDA registrations.