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

    URETERAL ILLUMINATOR

    K Number: K941506 · Decision Oct 5, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    9
    Applicant Total
    9
    Review Days
    190

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    Basic Information

    Device Name
    URETERAL ILLUMINATOR
    K Number
    K941506
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.4020
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Apple Medical Corp.
    Date Received
    March 29, 1994
    Decision Date
    October 5, 1994
    Product Code
    FCS
    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
    FCS Light, Catheter, Fiberoptic, Glass, Ureteral

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    Other Clearances by Apple Medical Corp.

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    K041131 APPLE MEDICAL OB MOBIUS ELASTIC RETRACTOR
    K014005 APPLE MEDICAL MOBIUS ELASTIC RETRACTOR
    K000026 APPLE MEDICAL ONE-TOUCH UTERINE SAMPLER
    K970788 PNEUMO-MATIC INSUFFLATION NEEDLE
    K961460 LWEET CONE BIOPSY INSTRUMENT
    K952841 THE ASSISTANT