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

    ELECTRO-CAUTERY SUCTION TUBE

    K Number: K881413 · Decision Apr 21, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    823
    Registration Numbers
    823
    Same Product Code
    2306
    Applicant Total
    10
    Review Days
    17

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    Basic Information

    Device Name
    ELECTRO-CAUTERY SUCTION TUBE
    K Number
    K881413
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4400
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Alto Development Corp.
    Date Received
    April 4, 1988
    Decision Date
    April 21, 1988
    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 Alto Development Corp.

    K Number Device Name
    K964621 A & E MEDICAL ELECTROCAUTERY SUCTION TUBE WITH FINGER TIP ACTIVATOR BUTTON
    K932513 LABELING FOR MYO/WIRE II STERNOTOMY SUTURES
    K931537 A&E MEDICAL ELECTROSURG ELECTRO W/NON-STICK COAT
    K930528 A&E MEDICAL ELECTROSURGICAL CONNECTING CORDS
    K914193 A&E MEDICAL CORP DISPOS SUCT COAG W/NON STICK COAT
    K915300 A & EM MEDICAL ELECTROSURGICAL PENCIL/ACCESSORIES
    K884783 RANEY CLIP
    K831867 PRESSURE MONITORING IV BOTTLE CAP
    K821518 MYO/CLIP