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

    UNIMED SUCTION-IRRIGATION ELECTRODE AND SLIDING SHEATH

    K Number: K963338 · Decision Oct 21, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    823
    Registration Numbers
    823
    Same Product Code
    2306
    Applicant Total
    13
    Review Days
    59

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    Basic Information

    Device Name
    UNIMED SUCTION-IRRIGATION ELECTRODE AND SLIDING SHEATH
    K Number
    K963338
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4400
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Unimed Surgical Products, Inc.
    Date Received
    August 23, 1996
    Decision Date
    October 21, 1996
    Product Code
    GEI
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    GEI Electrosurgical, Cutting & Coagulation & 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
    K962935 UNIMED COATED NEEDLE ELECTRODE/COATED BLADE ELECTRODE/COATED BALL ELECTRODE
    K944450 SURGI-LINK LLETZ NEEDLE ELECTRODE, LOOP ELECTRODE, SQUARE LOOP 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. →