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

    MODIFICATION TO SANARUS CENTRICA CORE TISSUE BIOPSY

    K Number: K022879 · Decision Sep 23, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    207
    Registration Numbers
    207
    Same Product Code
    360
    Applicant Total
    14
    Review Days
    24

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    Basic Information

    Device Name
    MODIFICATION TO SANARUS CENTRICA CORE TISSUE BIOPSY
    K Number
    K022879
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    876.1075
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Sanarus Medical, Inc.
    Date Received
    August 30, 2002
    Decision Date
    September 23, 2002
    Product Code
    KNW
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    KNW Instrument, Biopsy

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    Other Clearances by Sanarus Medical, Inc.

    K Number Device Name
    K080171 SANARUS INCORE ROTATIONAL CORE BIOPSY DEVICE, MODELS CB3010, CB3012
    K073533 SANARUS V2 TREATMENT SYSTEM
    K062896 V2 TREATMENT SYSTEM (V2 CONSOLE, V2 ICE PROBE, V2 DEWARS) MODELS; VS3000, VP0600, VD0600
    K061510 SANARUS VISICA TREATMENT SYSTEM
    K052861 MODIFICATION TO:SANARUS VISICA TREATMENT SYSTEM , MODELS VS2000
    K051581 SANARUS CASSI II ROTATIONAL CORE BIOPSY SYSTEM, MODEL CS2000
    K042136 SANARUS CASSI ROTATIONAL CORE BIOPSY SYSTEM
    K032506 SANARUS CENTRICA II ROTATIONAL CORE BIOPSY SYSTEM
    K020054 SANARUS INDICA MARKER SYSTEM
    K022314 SANARUS VISICA TREATMENT SYSTEM
    Search all 14 clearances from Sanarus Medical, Inc. →