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

    Cianna Medical SAVI Scout Reflector and SAVI Scout System

    K Number: K161507 · Decision Jul 29, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    2
    Applicant Total
    8
    Review Days
    58

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    Basic Information

    Device Name
    Cianna Medical SAVI Scout Reflector and SAVI Scout System
    K Number
    K161507
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4670
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Cianna Medical, Inc.
    Date Received
    June 1, 2016
    Decision Date
    July 29, 2016
    Product Code
    PDW
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    RA
    Third Party
    N

    Classifications

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

    Product Code Device Name
    PDW Internal Tissue Marker

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    Other Clearances by Cianna Medical, Inc.

    K Number Device Name
    K181007 Cianna Medical SAVI Scout Reflector and SAVI Scout System
    K171767 Cianna Medical SAVI Scout Reflector and SAVI Scout System
    K141318 CIANNA MEDICAL SGS SYSTEM
    K132463 CIANNA MEDICAL PERMANENT TISSUE MARKER AND DELIVERY SYSTEM
    K101411 SAVI PREPARATION DEVICE
    K081677 SAVI APPLICATOR KIT
    K080565 MODIFICATION TO: SAVI APPLICATOR KIT