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

    RESECTOSCOPE LOOPS

    K Number: K903323 · Decision Oct 1, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    117
    Registration Numbers
    117
    Same Product Code
    187
    Applicant Total
    142
    Review Days
    68

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    Basic Information

    Device Name
    RESECTOSCOPE LOOPS
    K Number
    K903323
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.4300
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Olympus Corp.
    Date Received
    July 25, 1990
    Decision Date
    October 1, 1990
    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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    K931763 HF-RESECTION ELECTRODE, LOOP W/RUNNER ENDOS/ACCESS
    K934835 FLOVAL
    K931764 HF RESECTION ELECTRODE, LOOP W/RUNNER HYSTER/ACCES
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    K931994 RESECTOSCOPE SHEATH
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