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

    SLT LASER CONTINUOUS FLOW TESECTOSCOPE (CFR)

    K Number: K936038 · Decision May 27, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    40
    Registration Numbers
    40
    Same Product Code
    23
    Applicant Total
    51
    Review Days
    158

    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
    SLT LASER CONTINUOUS FLOW TESECTOSCOPE (CFR)
    K Number
    K936038
    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 Laser Technologies, Inc.
    Date Received
    December 20, 1993
    Decision Date
    May 27, 1994
    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 Surgical Laser Technologies, Inc.

    K Number Device Name
    K042211 MODIFICATION TO: LASERPRO 810, 940, AND 980 DIODE DIODE LASER SYSTEMS
    K023624 SLT VENOUS FIBER DELIVERY SYSTEMS, MODEL: 0041-6772/0041-6781/0041-6752/0041-6761/0041-6912/0041-6921
    K011409 SLT LASERPRO CTH HOLMIUM LASER SYSTEM
    K010041 SLT DIFFUSER FIBER
    K984018 HEMOSLEEVE, MODEL 4.0MM, 5.5MM
    K983050 PNEUMATIC CUTTER SYSTEM
    K981041 SLT BIPOLAR SHEATH
    K972548 SLT CL MD CONTACT LASER SYSTEM
    K980156 SLT SELECT FIBER DELIVERY SYSTEM AND CONTACT TIPS
    K960821 SLT FUMICH PROBE GUIDE
    Search all 51 clearances from Surgical Laser Technologies, Inc. →