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

    Promisemed Safety Huber Needles

    K Number: K251138 · Decision May 13, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    25
    Registration Numbers
    25
    Same Product Code
    11
    Applicant Total
    31
    Review Days
    29

    Basic Information

    Device Name
    Promisemed Safety Huber Needles
    K Number
    K251138
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    880.5570
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Promisemed Hangzhou Meditech Co., Ltd.
    Date Received
    April 14, 2025
    Decision Date
    May 13, 2025
    Product Code
    PTI
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    PTI Non-Coring (Huber) Needle

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    Other Clearances by Promisemed Hangzhou Meditech Co., Ltd.

    K Number Device Name
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    K234124 Single Use Hemoclips
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    K223453 Insulin Syringe
    K223643 Verifine® Ease Lancing Device, Verifine® Lancing Device
    Search all 31 clearances from Promisemed Hangzhou Meditech Co., Ltd. →