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

    Sugita AVM Microclips

    K Number: K211183 · Decision Mar 2, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    35
    Applicant Total
    5
    Review Days
    316

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    Basic Information

    Device Name
    Sugita AVM Microclips
    K Number
    K211183
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.5200
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Mizuho America, Inc.
    Date Received
    April 20, 2021
    Decision Date
    March 2, 2022
    Product Code
    HCH
    Advisory Committee
    Neurology
    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
    HCH Clip, Aneurysm

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    Other Clearances by Mizuho America, Inc.

    K Number Device Name
    K221524 Sugita AVM Microclip Applier
    K990202 SUGITA TITANIUM ANEURYSM CLIP
    K960037 SUGITA AVM MICROCLIP
    K955012 MIZUHO RADIOLUCENT HEAD FRAME