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

    CLARUS MODEL 5197 SIGHTLITE

    K Number: K971455 · Decision May 20, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    1
    Applicant Total
    22
    Review Days
    29

    Basic Information

    Device Name
    CLARUS MODEL 5197 SIGHTLITE
    K Number
    K971455
    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
    April 21, 1997
    Decision Date
    May 20, 1997
    Product Code
    FTI
    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
    FTI Lamp, Endoscope, Incandescent

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (FTI), ordered by most recent decision date.

    OXFORD OPTRONIX MPM 3S

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology
    View all

    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)
    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
    K940144 CLARUS PHOENIX ENDOSCOPE
    Search all 22 clearances from CLARUS MEDICAL SYSTEMS, INC. →