BEUDAMED
    FDA 510(k) FDA class 2 Unknown 🇺🇸 United States

    QIKCAP System

    K Number: DEN250004 · Decision Dec 23, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    0
    Applicant Total
    1
    Review Days
    327

    Basic Information

    Device Name
    QIKCAP System
    K Number
    DEN250004
    Device Class
    FDA class 2
    Clearance Type
    Direct
    Regulation Number
    880.6512
    Medical Specialty
    General Hospital
    Decision
    Unknown
    Applicant
    Hai Solutions
    Date Received
    January 30, 2025
    Decision Date
    December 23, 2025
    Product Code
    SGX
    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
    SGX Ultraviolet Light-Based Microbial Reduction Device For Luer-Activated Valves