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

    Standard Staple-Line Reinforcement (SSLR23)

    K Number: K231603 · Decision Oct 6, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    21
    Registration Numbers
    21
    Same Product Code
    8
    Applicant Total
    2
    Review Days
    127

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    Basic Information

    Device Name
    Standard Staple-Line Reinforcement (SSLR23)
    K Number
    K231603
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.3300
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Standard Bariatrics, Inc.
    Date Received
    June 1, 2023
    Decision Date
    October 6, 2023
    Product Code
    OXC
    Advisory Committee
    General, Plastic Surgery
    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
    OXC Mesh, Surgical, Absorbable, Staple Line Reinforcement

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    Other Clearances by Standard Bariatrics, Inc.

    K Number Device Name
    K222085 Standard Tapered Bougie, 38 Fr.