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

    SLT BIPOLAR SHEATH

    K Number: K981041 · Decision Aug 27, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    131
    Registration Numbers
    131
    Same Product Code
    90
    Applicant Total
    51
    Review Days
    160

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    Basic Information

    Device Name
    SLT BIPOLAR SHEATH
    K Number
    K981041
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    874.4250
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Surgical Laser Technologies, Inc.
    Date Received
    March 20, 1998
    Decision Date
    August 27, 1998
    Product Code
    ERL
    Advisory Committee
    Ear, Nose, Throat
    Review Advisory Committee
    EN
    Third Party
    N

    Classifications

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

    Product Code Device Name
    ERL Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece

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    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
    K972548 SLT CL MD CONTACT LASER SYSTEM
    K980156 SLT SELECT FIBER DELIVERY SYSTEM AND CONTACT TIPS
    K960821 SLT FUMICH PROBE GUIDE
    K954727 SLT MULTIDIMENSIONAL CONTACT LASER SYSTEM (MODIFICATION)
    Search all 51 clearances from Surgical Laser Technologies, Inc. →