BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇮🇹 Italy

    DISKOM

    K Number: K180315 · Decision Mar 26, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    386
    Registration Numbers
    386
    Same Product Code
    680
    Applicant Total
    4
    Review Days
    49

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    Basic Information

    Device Name
    DISKOM
    K Number
    K180315
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.1100
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Biopsybell S.R.L.
    Date Received
    February 5, 2018
    Decision Date
    March 26, 2018
    Product Code
    HRX
    Advisory Committee
    Orthopedic
    Review Advisory Committee
    OR
    Third Party
    N

    Classifications

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

    Product Code Device Name
    HRX Arthroscope

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    Other Clearances by Biopsybell S.R.L.

    K Number Device Name
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    K203397 Marrow-Pack (white)- 11gauge/10cm or 13gauge/10cm, Marrow-Tray (red)- 11gauge/10cm or 13gauge/10cm, Marrow-Set (violet)- 11gauge/10cm or 13gauge/10cm, Marrow-kit (grey)- 11gauge/10cm or 13gauge/10cm, Marrow-Stem (green)- 11gauge/10cm or 13gauge/10cm
    K130616 MANUAL-BONE-MARROW-BIOPSY-NEEDLES, SEMI-AUTOMATIC-BIOPSY-NEEDLES, AUTOMATIC-BIOPSY-NEEDLES