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

    SURGI-LINK LLETZ NEEDLE ELECTRODE, LOOP ELECTRODE, SQUARE LOOP ELECTRODE

    K Number: K944450 · Decision Jul 25, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    66
    Registration Numbers
    66
    Same Product Code
    52
    Applicant Total
    13
    Review Days
    316

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    Basic Information

    Device Name
    SURGI-LINK LLETZ NEEDLE ELECTRODE, LOOP ELECTRODE, SQUARE LOOP ELECTRODE
    K Number
    K944450
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.4120
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Unimed Surgical Products, Inc.
    Date Received
    September 12, 1994
    Decision Date
    July 25, 1995
    Product Code
    HGI
    Advisory Committee
    Obstetrics/Gynecology
    Review Advisory Committee
    OB
    Third Party
    N

    Classifications

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

    Product Code Device Name
    HGI Electrocautery, Gynecologic (And Accessories)

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    Other Clearances by Unimed Surgical Products, Inc.

    K Number Device Name
    K132224 UNIMED SURGICAL COATED ELECTROSURGICAL ELECTRODES
    K993647 UNIMED DISPOSABLE HAND AND FOOT-SWITCHING PENCILS WITH HOLSTER AND 1BLADE AND TIP CLEANER, UNIMED DISPOSABLE HAND AND F
    K970066 UNIMED COATED LAPAROSCOPIC/ARTHROSCOPY/SUCTION-IRRIGATION ELECTRODE
    K963338 UNIMED SUCTION-IRRIGATION ELECTRODE AND SLIDING SHEATH
    K962935 UNIMED COATED NEEDLE ELECTRODE/COATED BLADE ELECTRODE/COATED BALL ELECTRODE
    K944265 NEEDLE ELCTRODE
    K946246 SURGI-LINK BIPOLAR MICRO FORCEPS
    K945030 SURGI-LINK LAPAROSCOPIC ELECTRODES
    K944898 SURGI-LINK BIPOLAR ELECTRODES
    K944617 SURGI-LINK DISPOSABLE PUSH BUTTON ESU PENCIL
    Search all 13 clearances from Unimed Surgical Products, Inc. →