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

    Tisuthes e-PTFE Surgical Patch

    K Number: K201153 · Decision Jun 13, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    0
    Applicant Total
    1
    Review Days
    1139

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    Basic Information

    Device Name
    Tisuthes e-PTFE Surgical Patch
    K Number
    K201153
    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
    Shanghai Suokang Medical Implants Co., Ltd.
    Date Received
    April 30, 2020
    Decision Date
    June 13, 2023
    Product Code
    OWR
    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
    OWR Mesh, Surgical, Non-Absorbable, Facial Implants For Plastic Surgery