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

    SANARUS VISICA TREATMENT SYSTEM

    K Number: K061510 · Decision Jul 18, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    83
    Registration Numbers
    83
    Same Product Code
    261
    Applicant Total
    14
    Review Days
    47

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    Basic Information

    Device Name
    SANARUS VISICA TREATMENT SYSTEM
    K Number
    K061510
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    878.4350
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Sanarus Medical, Inc.
    Date Received
    June 1, 2006
    Decision Date
    July 18, 2006
    Product Code
    GEH
    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
    GEH Unit, Cryosurgical, Accessories

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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
    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
    K022879 MODIFICATION TO SANARUS CENTRICA CORE TISSUE BIOPSY
    Search all 14 clearances from Sanarus Medical, Inc. →