BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇩🇪 Germany

    Tumark Vision, Tumark Professional, Tumark Q, Tumark Professional Q-Shape

    K Number: K201863 · Decision Feb 18, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    102
    Registration Numbers
    102
    Same Product Code
    109
    Applicant Total
    7
    Review Days
    227

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    Basic Information

    Device Name
    Tumark Vision, Tumark Professional, Tumark Q, Tumark Professional Q-Shape
    K Number
    K201863
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4300
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Somatex Medical Technologies GmbH
    Date Received
    July 6, 2020
    Decision Date
    February 18, 2021
    Product Code
    NEU
    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
    NEU Marker, Radiographic, Implantable

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    Other Clearances by Somatex Medical Technologies GmbH

    K Number Device Name
    K182082 Tumark for Eviva, Tumark for Brevera
    K180443 Tumark Vision
    K111692 TUMARK FLEX FOR MAMMOTOME,TUMARK FLEX FOR ATEC
    K102771 BIOPSY HANDY, MRI BIOPSY HANDY
    K093064 TUMARK PROFESSIONAL, MODEL 271560, MR-TUMARK PROFESSIONAL, MODEL 601560
    K073095 TUMARK PROFESSIONAL, MODEL 271560; MR- TUMARK PROFESSIONAL, MODEL 601560