BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇳 China

    EEA™Circular Stapler with Tri-Staple™ Technology and OrVil™ Transoral Circular Stapler Anvil

    K Number: K232126 · Decision Aug 16, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    76
    Registration Numbers
    76
    Same Product Code
    41
    Applicant Total
    130
    Review Days
    30

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    Basic Information

    Device Name
    EEA™Circular Stapler with Tri-Staple™ Technology and OrVil™ Transoral Circular Stapler Anvil
    K Number
    K232126
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    878.4740
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Covidien
    Date Received
    July 17, 2023
    Decision Date
    August 16, 2023
    Product Code
    GAG
    Advisory Committee
    General Hospital
    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
    GAG Stapler, Surgical

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