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

    PUMA-G System

    K Number: K223916 · Decision Mar 29, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    25
    Registration Numbers
    25
    Same Product Code
    25
    Applicant Total
    2
    Review Days
    90

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    Basic Information

    Device Name
    PUMA-G System
    K Number
    K223916
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5980
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Coaptech, Inc.
    Date Received
    December 29, 2022
    Decision Date
    March 29, 2023
    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 Coaptech, Inc.

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