BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    ANSPACH ACCESS CRANIAL PERFORATOR

    K Number: K982991 · Decision Oct 21, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    28
    Registration Numbers
    28
    Same Product Code
    17
    Applicant Total
    60
    Review Days
    55

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    ANSPACH ACCESS CRANIAL PERFORATOR
    K Number
    K982991
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.4305
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    The Anspach Effort, Inc.
    Date Received
    August 27, 1998
    Decision Date
    October 21, 1998
    Product Code
    HBF
    Advisory Committee
    Neurology
    Review Advisory Committee
    NE
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    HBF Drills, Burrs, Trephines & Accessories (Compound, Powered)

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (HBF), ordered by most recent decision date.

    evoDrill Cranial Perforator

    FDA 510(k)
    FDA Class 2 ·Neurology

    NeuroLine Disposable Cranial Perforator with Hudson end

    FDA 510(k)
    FDA Class 2 ·Neurology

    Codman Disposable Perforators

    FDA 510(k)
    FDA Class 2 ·Neurology

    EASYDRILL AUTOSTOP CRANIAL PERFORATOR

    FDA 510(k)
    FDA Class 2 ·Neurology

    MERIDIAN CRANIAL PERFORATOR

    FDA 510(k)
    FDA Class 2 ·Neurology

    STRYKER DISPOSABLE CRANIAL PERFORATOR BIT

    FDA 510(k)
    FDA Class 2 ·Neurology
    View all

    Other Clearances by The Anspach Effort, Inc.

    K Number Device Name
    K220485 Wireless Hand Control, EG1A (WIRELESS-HC), Receiver for Wireless Hand Control, EG1A (RECEIVER-HC)
    K183545 Anspach Helix Dissection Tools
    K180063 OCM-G1 Attachment
    K133604 ANSPACH EG1 HIGH SPEED SYSTEM, G1 ATTACHMENTS
    K131053 ANSPACH XMAX, EMAX2 AND EMAX2 PLUS SYSTEM WITH OTOLOGIC ATTACHMENT SYSTEM
    K113476 ANSPACH DISSECTION TOOLS
    K082637 CRANIAL PERFORATOR
    K080802 EMAX 2 PLUS SYSTEM, MODEL EMAX 2 PLUS MOTOR, EMAX 2 CONSOLE>FIRMWARE UPGRADE, EMAX 2 FP FOOT PEDAL
    K061297 ANSPACH IMRI SAFE SURGICAL DRILL SYSTEM
    K063688 SURGICAL IRRIGATION SYSTEM, IRRIGATION TUBE
    Search all 60 clearances from The Anspach Effort, Inc. →