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

    MODIFICATION TO OLYMPUS CAPSULE ENDOSCOPE SYSTEM

    K Number: K090210 · Decision Jul 29, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    16
    Registration Numbers
    16
    Same Product Code
    46
    Applicant Total
    81
    Review Days
    182

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    Basic Information

    Device Name
    MODIFICATION TO OLYMPUS CAPSULE ENDOSCOPE SYSTEM
    K Number
    K090210
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    876.1300
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Olympus Medical Systems Corporation
    Date Received
    January 28, 2009
    Decision Date
    July 29, 2009
    Product Code
    NEZ
    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
    NEZ System, Imaging, Gastrointestinal, Wireless, Capsule

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    K252247 Injector Force Max Single Use Injector (NM-400L); Injector Force Max Single Use Injector (NM-400U); Injector Force Max Single Use Injector (NM-400Y); Injector Force Max Single Use Injector (NM-401L)
    K250351 Single Use Electrosurgical Knife (KD-612L, KD-612U); Single Use Electrosurgical Knife (KD-620UR); Single Use Electrosurgical Knife (KD-650L, KD-650U)
    K252150 Ultrasonic Bipolar Generator (USG-410); Reuseable Cordless Transducer (TD-410); THUNDERBEAT II Shears with Ultrasonic Mode, 5mm, 45cm (TB2-0545FC); THUNDERBEAT II Shears with Ultrasonic Mode, 5mm, 35cm (TB2-0535FC); THUNDERBEAT II Shears with Ultrasonic Mode, 5mm, 25cm (TB2-0525FC); THUNDERBEAT II Shears with Ultrasonic Mode, 5mm, 20cm (TB2-0520FC)
    K250187 Disposable Hot Biopsy Forceps (FD-210U); Disposable Hot Biopsy Forceps (FD-230U)
    K251859 EVIS EUS Ultrasound Gastrointestinal Videoscope (Olympus GF-UE190)
    K251986 AUXILIARY WATER TUBE MAJ-855
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