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

    Monteris Medical NeuroBlate System

    K Number: K240877 · Decision Jun 4, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7
    Same Product Code
    6
    Applicant Total
    11
    Review Days
    67

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    Basic Information

    Device Name
    Monteris Medical NeuroBlate System
    K Number
    K240877
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4810
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Monteris Medical,
    Date Received
    March 29, 2024
    Decision Date
    June 4, 2024
    Product Code
    ONO
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    NE
    Third Party
    N

    Classifications

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

    Product Code Device Name
    ONO Neurosurgical Laser With Mr Thermography

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    Other Clearances by Monteris Medical,

    K Number Device Name
    K231061 NeuroBlate System
    K222983 NeuroBlate Fusion-S Software V3.17
    K193375 NeuroBlate System
    K182036 NeuroBlate System
    K173305 NeuroBlate System
    K172881 NeuroBlate System
    K170724 NeuroBlate System
    K132444 ATAMA SYSTEM
    K090240 MONTERIS MEDICAL UFO
    K081509 MONTERIS MEDICAL AUTOLITT LASER PROBE
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