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

    RUBICOR BREAST BIOPSY DEVICE

    K Number: K020047 · Decision Apr 5, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    823
    Registration Numbers
    823
    Same Product Code
    2306
    Applicant Total
    8
    Review Days
    88

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    Basic Information

    Device Name
    RUBICOR BREAST BIOPSY DEVICE
    K Number
    K020047
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4400
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Rubicor Medical, Inc.
    Date Received
    January 7, 2002
    Decision Date
    April 5, 2002
    Product Code
    GEI
    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
    GEI Electrosurgical, Cutting & Coagulation & Accessories

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    Other Clearances by Rubicor Medical, Inc.

    K Number Device Name
    K071048 RUBICOR MAGIC BREAST BIOPSY DEVICE, MODEL 31537
    K070275 FLEXIBLE LOOP ELECTROSURGICAL ELECTRODE
    K053151 RUBICOR MAGIC BREAST BIOPSY DEVICE
    K052506 RUBICOR ENCAPSULE BREAST BIOPSY DEVICE, MODEL 31108
    K032584 RUBICOR ENCAPSULE BREAST BIOPSY DEVICE, MODEL 30629
    K030049 MODIFICATION TO RUBICOR ENCAPSULE BREAST BIOPSY DEVICE, MODEL 30086
    K023601 RUBICOR ENCAPSULE BREAST BIOPSY DEVICE, MODEL 30086