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

    JTECH 50 SERIES CUTTING LOOP

    K Number: K913587 · Decision Oct 23, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    40
    Registration Numbers
    40
    Same Product Code
    23
    Applicant Total
    5
    Review Days
    72

    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
    JTECH 50 SERIES CUTTING LOOP
    K Number
    K913587
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    J-Tech, Inc.
    Date Received
    August 12, 1991
    Decision Date
    October 23, 1991
    Product Code
    FJL
    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
    FJL Resectoscope

    Similar 510(k) Clearances

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

    KARL STORZ Monopolar Resectoscopes with HF Cable

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

    KARL STORZ Bipolar Resectoscopes with HF Cable

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

    Veloxion System

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

    Veloxion Controller Kit, Veloxion Fluid Control Set, Veloxion Resectoscope, Veloxion Video Control Unit, Veloxion Roll Stand, Waste Management Tubing, Tissue Catch, Waste Management Bags

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

    Veloxion Controller Kit, Veloxion Fluid Control Kit, Veloxion Resectoscope, Veloxion Video Control Unit, Veloxion Roll Stand, Waste Management Tubing, Tissue Catch

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

    Veloxion System

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

    Other Clearances by J-Tech, Inc.

    K Number Device Name
    K954737 SURFACE ELECTROMYOGRAPH BIOFEEDBACK MUSCLE ACTIVITY DEVICE
    K954647 INCLINOMETER
    K945630 LARGE MUSCLE STRENGTH GAUGE
    K912526 GS-220 HAND IMPAIRMENT EVALUATION SYSTEM