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

    ACCUTECH ENDOLITE PROBE

    K Number: K061025 · Decision May 31, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    24
    Registration Numbers
    24
    Same Product Code
    25
    Applicant Total
    2
    Review Days
    48

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    ACCUTECH ENDOLITE PROBE
    K Number
    K061025
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Accutech Medical Technologies, Inc.
    Date Received
    April 13, 2006
    Decision Date
    May 31, 2006
    Product Code
    FFS
    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
    FFS Image, Illumination, Fiberoptic, For Endoscope

    Similar 510(k) Clearances

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

    COOK FIBER OPTIC BUNDLE AND FLEXOR DEFLECTING ACCESS SHEATH

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

    PS SERIES

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

    TRU-CABLE

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

    SOVIS OPTIQUE'S ENDOSCOPIC CABLE

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

    MICRO LINK ENDOSCOPIC FIBER CABLE, MODEL B1-90159

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

    SMITH & NEPHEW XENON LIGHT SOURCES AND ACCESSORIES

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

    Other Clearances by Accutech Medical Technologies, Inc.

    K Number Device Name
    K090281 ACCUTECH FAMILY OF POWERFLEX LASER DELIVERY DEVICES