BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇰🇷 South Korea

    AFS Medical Sterile Single-Use Access Port System

    K Number: K202688 · Decision Oct 14, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    10
    Applicant Total
    1
    Review Days
    394

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    Basic Information

    Device Name
    AFS Medical Sterile Single-Use Access Port System
    K Number
    K202688
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Afs Medical Co. , Ltd.
    Date Received
    September 15, 2020
    Decision Date
    October 14, 2021
    Product Code
    OTJ
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    OTJ Laparoscopic Single Port Access Device

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