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

    CLARUS PHOENIX ENDOSCOPE

    K Number: K940144 · Decision Apr 25, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    386
    Registration Numbers
    386
    Same Product Code
    680
    Applicant Total
    22
    Review Days
    469

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    Basic Information

    Device Name
    CLARUS PHOENIX ENDOSCOPE
    K Number
    K940144
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.1100
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Clarus Medical Systems, Inc.
    Date Received
    January 11, 1994
    Decision Date
    April 25, 1995
    Product Code
    HRX
    Advisory Committee
    Orthopedic
    Review Advisory Committee
    OR
    Third Party
    N

    Classifications

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

    Product Code Device Name
    HRX Arthroscope

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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. →