BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Light Source System, Diagnostic Endoscopic

    PMA: P050027 · Supplement: S014 · Decision Feb 21, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11

    Basic Information

    Device Name
    Light Source System, Diagnostic Endoscopic
    Trade Name
    KARL STORZ PHOTODYNAMIC DIAGNOSTIC D-LIGHT C (PDD) SYSTEM
    PMA Number
    P050027
    Supplement Number
    S014
    Device Class
    FDA Class 3
    Product Code
    OAY
    Generic Name
    Light source system, diagnostic endoscopic
    Medical Specialty
    Unknown
    Advisory Committee
    Gastroenterology, Urology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    February 21, 2019
    Date Received
    September 17, 2018
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval for the following alternate sterilization methods for the Flexible PDD Video Cystoscopes (P/N: 11272VNIA and 11272VNIUA): STERRAD NX Advanced Cycle, STERRAD 100 NX Flex and Duo Cycles, STERIS V-PRO maX Flexible Cycle and Steris V-PRO 60 Flexible Cycle.

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    OAY Light Source System, Diagnostic Endoscopic