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

    STARION UNIVERSAL POWER SUPPLY (UPS)

    K Number: K043155 · Decision Dec 9, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    11
    Applicant Total
    13
    Review Days
    24

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    Basic Information

    Device Name
    STARION UNIVERSAL POWER SUPPLY (UPS)
    K Number
    K043155
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    886.4115
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Starion Instruments
    Date Received
    November 15, 2004
    Decision Date
    December 9, 2004
    Product Code
    HQO
    Advisory Committee
    Ophthalmic
    Review Advisory Committee
    OP
    Third Party
    N

    Classifications

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

    Product Code Device Name
    HQO Unit, Cautery, Thermal, Ac-Powered

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    Other Clearances by Starion Instruments

    K Number Device Name
    K070871 STARION UNIVERSAL POWER SUPPLY
    K062257 STARION INSTRUMENTS THERMAL LITIGATING SHEARS
    K050308 THERMAL CAUTERY PROBE
    K002547 STARION INSTRUMENTS POWER POINT CAUTERY GRASPER/DISSECTOR
    K001273 STARION INSTRUMENTS POWER POINT CAUTERY CLAMP
    K000893 AC POWERED THERMAL CAUTERY UNIT
    K001262 THERMAL CAUTERY FORCEPS
    K000250 CAUTERY FORCEPS WITH FOOTSWITCH
    K000296 STARION CAUTERY HOOK
    K994019 CAUTERY GRASPER/DISSECTOR
    Search all 13 clearances from Starion Instruments →