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

    A & E MEDICAL ELECTROCAUTERY SUCTION TUBE WITH FINGER TIP ACTIVATOR BUTTON

    K Number: K964621 · Decision Dec 20, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    823
    Registration Numbers
    823
    Same Product Code
    2306
    Applicant Total
    10
    Review Days
    32

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    Basic Information

    Device Name
    A & E MEDICAL ELECTROCAUTERY SUCTION TUBE WITH FINGER TIP ACTIVATOR BUTTON
    K Number
    K964621
    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
    Alto Development Corp.
    Date Received
    November 18, 1996
    Decision Date
    December 20, 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 Alto Development Corp.

    K Number Device Name
    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
    K881413 ELECTRO-CAUTERY SUCTION TUBE
    K831867 PRESSURE MONITORING IV BOTTLE CAP
    K821518 MYO/CLIP