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

    INFINITECH LIGHTED INFUSION CANNULA

    K Number: K946136 · Decision Oct 2, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    28
    Registration Numbers
    28
    Same Product Code
    39
    Applicant Total
    28
    Review Days
    290

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    Basic Information

    Device Name
    INFINITECH LIGHTED INFUSION CANNULA
    K Number
    K946136
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Surgical Technologies, Inc.
    Date Received
    December 16, 1994
    Decision Date
    October 2, 1995
    Product Code
    MPA
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    OP
    Third Party
    N

    Classifications

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

    Product Code Device Name
    MPA Endoilluminator

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    Other Clearances by Surgical Technologies, Inc.

    K Number Device Name
    K941992 CYSTOSCOPE
    K942029 ARTHROSCOPE
    K952566 OSCILFLATOR
    K951918 SURGICAL TECHNOLOGIES, INC. SYRINGE
    K950683 ARTHROGRAM TRAY
    K946135 INFINITECH ASPIRATING LASER PROBE
    K946181 INFINITECH SOFT TIP FLUTE NEEDLE
    K942030 BIOPSY SCISSORS
    K942482 PRESSURE MONITORING EXTENSION
    K941161 FLEXIBLE GRASPING FORCEPS
    Search all 28 clearances from Surgical Technologies, Inc. →