BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇯🇵 Japan

    NEOVEIL

    K Number: K130997 · Decision Nov 15, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    21
    Registration Numbers
    21
    Same Product Code
    8
    Applicant Total
    5
    Review Days
    219

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    Basic Information

    Device Name
    NEOVEIL
    K Number
    K130997
    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
    Gunze Limited
    Date Received
    April 10, 2013
    Decision Date
    November 15, 2013
    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

    Other 510(k) clearances with the same product code (OXC), ordered by most recent decision date.

    ECHELON ENDOPATH Staple Line Reinforcement (ECH60R)

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    Standard Staple-Line Reinforcement (SSLR23)

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    ECHELON ENDOPATH Staple Line Reinforcement

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    NEOVEIL Staple Line Reinforcement

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    FDA Class 2 ·General, Plastic Surgery

    Echelon Endopath Staple Line Reinforcement

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    GORE SEAMGUARD Bioabsorbable Staple Line Reinforcement

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    View all

    Other Clearances by Gunze Limited

    K Number Device Name
    K221487 NEOVEIL Staple Line Reinforcement
    K213498 PELNAC Meshed Bilayer Wound Matrix
    K213573 PELNAC Wound Matrix
    K191992 PELNAC Bilayer Wound Matrix