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

    ECHELON ENDOPATH Staple Line Reinforcement (ECH60R)

    K Number: K252906 · Decision Jan 9, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    21
    Registration Numbers
    21
    Same Product Code
    8
    Applicant Total
    69
    Review Days
    119

    Basic Information

    Device Name
    ECHELON ENDOPATH Staple Line Reinforcement (ECH60R)
    K Number
    K252906
    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
    Ethicon Endo-Surgery, LLC
    Date Received
    September 12, 2025
    Decision Date
    January 9, 2026
    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

    Similar 510(k) Clearances

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