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

    Promisemed Safety Huber Needle

    K Number: K230715 · Decision Jun 8, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    31
    Registration Numbers
    31
    Same Product Code
    12
    Applicant Total
    35
    Review Days
    85

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    Basic Information

    Device Name
    Promisemed Safety Huber Needle
    K Number
    K230715
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5570
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Promisemed Hangzhou Meditech Co., Ltd.
    Date Received
    March 15, 2023
    Decision Date
    June 8, 2023
    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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