BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇬🇧 United Kingdom

    Creo Medical Electrosurgical System including Speedboat RS2 Surgical Accessory

    K Number: K171983 · Decision Aug 17, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    117
    Registration Numbers
    117
    Same Product Code
    187
    Applicant Total
    10
    Review Days
    48

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    Basic Information

    Device Name
    Creo Medical Electrosurgical System including Speedboat RS2 Surgical Accessory
    K Number
    K171983
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.4300
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Creo Medical, Ltd.
    Date Received
    June 30, 2017
    Decision Date
    August 17, 2017
    Product Code
    KNS
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    KNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories)

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    Other Clearances by Creo Medical, Ltd.

    K Number Device Name
    K242774 SpydrBlade Flex Instrument (PRD-RG1-001)
    K242983 CROMA Electrosurgical Generator (PRD-EMR-050)
    K242061 Reusable Interface Cable 1.5 m (PRD-IFC-002)
    K230328 Speedboat Flush SB1 Instrument
    K223138 AB1 Electrosurgical Instrument, Creo Electrosurgical System
    K221672 Creo Electrosurgical System with NP1 Instrument
    K200298 ABI Instrument, Creo Electrosurgical System
    K200003 NP1 Instrument, Creo Electrosurgical System
    K192905 Creo Electrosurgical System with HS1 Hemostasis Accessory