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

    AMT Suture Delivery System

    K Number: K193612 · Decision Mar 12, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    25
    Registration Numbers
    25
    Same Product Code
    25
    Applicant Total
    25
    Review Days
    77

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    Basic Information

    Device Name
    AMT Suture Delivery System
    K Number
    K193612
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5980
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Applied Medical Technology, Inc.
    Date Received
    December 26, 2019
    Decision Date
    March 12, 2020
    Product Code
    KGC
    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
    KGC Tube, Gastro-Enterostomy

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    Other Clearances by Applied Medical Technology, Inc.

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    K180026 Bowel Management Device, Bowel Management Irrigation Set
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