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

    CLARUS SERIRS 2200 SEMI-RIGID ENDOSCOPE

    K Number: K924554 · Decision Feb 25, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    40
    Applicant Total
    22
    Review Days
    169

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    Basic Information

    Device Name
    CLARUS SERIRS 2200 SEMI-RIGID ENDOSCOPE
    K Number
    K924554
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Clarus Medical Systems, Inc.
    Date Received
    September 9, 1992
    Decision Date
    February 25, 1993
    Product Code
    LYK
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

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

    Product Code Device Name
    LYK Angioscope

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    Other Clearances by Clarus Medical Systems, Inc.

    K Number Device Name
    K980588 CLARUS ENDOSCOPIC DISCECTOMY SYSTEM SITETRAC MODEL 6000
    K974579 PERCSCOPE MODEL 2600
    K971584 CLARUS MODEL 2127-900 SERIES ENDOSCOPE ADATER (2127-900 SERIES)
    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
    K953685 INSTRUMENT SCOPE
    K945633 NEURO CHANNEL ENDOSCOPE MODEL 2232
    K945296 CLARUS PHOENIX NEURO ENDOSCOPE MODEL 2160
    Search all 22 clearances from Clarus Medical Systems, Inc. →