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

    Wireless Hand Control, EG1A (WIRELESS-HC), Receiver for Wireless Hand Control, EG1A (RECEIVER-HC)

    K Number: K220485 · Decision May 19, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    49
    Registration Numbers
    49
    Same Product Code
    25
    Applicant Total
    60
    Review Days
    91

    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
    Wireless Hand Control, EG1A (WIRELESS-HC), Receiver for Wireless Hand Control, EG1A (RECEIVER-HC)
    K Number
    K220485
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.4360
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    The Anspach Effort, Inc.
    Date Received
    February 17, 2022
    Decision Date
    May 19, 2022
    Product Code
    HBC
    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
    HBC Motor, Drill, Electric

    Similar 510(k) Clearances

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

    Traus SSG10 Surgical System

    FDA 510(k)
    FDA Class 2 ·Neurology

    Traus SSG30 Surgical System

    FDA 510(k)
    FDA Class 2 ·Neurology

    ORiGO System

    FDA 510(k)
    FDA Class 2 ·Neurology

    hekaDrill

    FDA 510(k)
    FDA Class 2 ·Neurology

    MR8 Drill System, Midas Rex MR8 ClearView Tools

    FDA 510(k)
    FDA Class 2 ·Neurology

    OSSEODUO Shaver and Drill System

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

    Other Clearances by The Anspach Effort, Inc.

    K Number Device Name
    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
    K052572 ANSPACH KNOTLESS ANCHOR
    Search all 60 clearances from The Anspach Effort, Inc. →