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

    CapsoCam Plus (SV-3)

    K Number: K183192 · Decision Apr 19, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    16
    Registration Numbers
    16
    Same Product Code
    46
    Applicant Total
    6
    Review Days
    151

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    Basic Information

    Device Name
    CapsoCam Plus (SV-3)
    K Number
    K183192
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    876.1300
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    CapsoVision, Inc.
    Date Received
    November 19, 2018
    Decision Date
    April 19, 2019
    Product Code
    NEZ
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    NEZ System, Imaging, Gastrointestinal, Wireless, Capsule

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    Other Clearances by CapsoVision, Inc.

    K Number Device Name
    K252480 CE Deliver (DLV)
    K242643 CapsoCam Plus (SV-3) Capsule Endoscopy System
    K192662 CapsoCam Plus (SV-3) Capsule Endoscopy System
    K161773 CapsoCam Plus (SV-3) Capsule Endoscope System
    K151635 CapsoCam (SV-1)