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

    Verisafe Safety Sterile Needles (SSN)

    K Number: K254273 · Decision Apr 16, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    440
    Registration Numbers
    440
    Same Product Code
    687
    Applicant Total
    35
    Review Days
    107

    Basic Information

    Device Name
    Verisafe Safety Sterile Needles (SSN)
    K Number
    K254273
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    880.5570
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Promisemed Hangzhou Meditech Co., Ltd.
    Date Received
    December 30, 2025
    Decision Date
    April 16, 2026
    Product Code
    FMI
    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
    FMI Needle, Hypodermic, Single Lumen

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