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

    Sterile single use tip cleaner (WK800-S10 , WK800-S20)

    K Number: K241022 · Decision Jul 11, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    823
    Registration Numbers
    823
    Same Product Code
    2306
    Applicant Total
    6
    Review Days
    87

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    Basic Information

    Device Name
    Sterile single use tip cleaner (WK800-S10 , WK800-S20)
    K Number
    K241022
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4400
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Wickimed (Huizhou) Medical Equipment Manufacturing Co.,Ltd
    Date Received
    April 15, 2024
    Decision Date
    July 11, 2024
    Product Code
    GEI
    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
    GEI Electrosurgical, Cutting & Coagulation & Accessories

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    Other Clearances by Wickimed (Huizhou) Medical Equipment Manufacturing Co.,Ltd

    K Number Device Name
    K222828 Specimen Bag, model: WEP040306B, WEP010304B, WEP040304B, WEP010759B, WEP010709B, WEP010304A, WEP010759A, WEP010709A
    K172578 Equipment Pouch
    K172794 Suction Irrigation Set
    K172038 Trocar
    K172120 Veress Needle