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

    INSTRUMENT SCOPE

    K Number: K953685 · Decision Oct 12, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    65
    Registration Numbers
    65
    Same Product Code
    92
    Applicant Total
    22
    Review Days
    66

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    Basic Information

    Device Name
    INSTRUMENT SCOPE
    K Number
    K953685
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.1480
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Clarus Medical Systems, Inc.
    Date Received
    August 7, 1995
    Decision Date
    October 12, 1995
    Product Code
    GWG
    Advisory Committee
    Neurology
    Review Advisory Committee
    NE
    Third Party
    N

    Classifications

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

    Product Code Device Name
    GWG Endoscope, Neurological

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    Other Clearances by Clarus Medical Systems, Inc.

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    K971455 CLARUS MODEL 5197 SIGHTLITE
    K960915 CLARUS NEUROPEN ENDOSCOPIC PLACEMENT KIT MODEL 2125-XXX
    K962255 CLARUS MURPHYPEN ENDOSCOPE(2127-XXX)
    K955598 CLARUS SPINEPEN MODEL 2126
    K945633 NEURO CHANNEL ENDOSCOPE MODEL 2232
    K945296 CLARUS PHOENIX NEURO ENDOSCOPE MODEL 2160
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