BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇸🇪 Sweden

    BONOPTY COAXIAL BONE BIOPSY SYSTEM WITH ECCENTRIC DRILL(10-1072,3,4)

    K Number: K962425 · Decision Sep 11, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    321
    Registration Numbers
    322
    Same Product Code
    106
    Applicant Total
    24
    Review Days
    79

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    Basic Information

    Device Name
    BONOPTY COAXIAL BONE BIOPSY SYSTEM WITH ECCENTRIC DRILL(10-1072,3,4)
    K Number
    K962425
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4800
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Radi Medical Systems AB
    Date Received
    June 24, 1996
    Decision Date
    September 11, 1996
    Product Code
    GAA
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    GAA Needle, Aspiration And Injection, Disposable

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    Other Clearances by Radi Medical Systems AB

    K Number Device Name
    K123984 QUANTIEN MEASUREMENT SYSTEM
    K092105 RADIANALYZER XPRESS
    K080813 PRESSUREWIRE CERTUS, CERTUS (300CM), AERIS, AERIS (300CM), RECEIVER
    K080206 MODIFICATION TO FEMOSTOP FEMORAL COMPRESSION SYSTEM
    K062769 PRESSUREWIRE CERTUS, MODELS 12006 AND 12306
    K042628 MODIFICATION TO: RADIANALYZER, MODEL 12711
    K033291 TOPSEAL HEMOSTATIC DRESSING, MODEL 11150
    K031662 PRESSURE WIRE SENSOR, MODELS 12004/12304
    K024107 FEMOSTOP FEMORAL COMPRESSION SYSTEM
    K022188 RADIANALYZER, MODEL 12710
    Search all 24 clearances from Radi Medical Systems AB →