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

    MODIFICATION TO TISSUELINK BIPOLAR FORCEPS

    K Number: K010661 · Decision May 3, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    823
    Registration Numbers
    823
    Same Product Code
    2306
    Applicant Total
    12
    Review Days
    63

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    Basic Information

    Device Name
    MODIFICATION TO TISSUELINK BIPOLAR FORCEPS
    K Number
    K010661
    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
    Tissuelink Medical, Inc.
    Date Received
    March 1, 2001
    Decision Date
    May 3, 2001
    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 Tissuelink Medical, Inc.

    K Number Device Name
    K073495 TISSUELINK AQUAMANTYS MALLEABLE BIPOLAR SEALER WITH LIGHT
    K063639 AQUAMANTYS SS4.0 BIPOLAR SEALER, MODEL 23-121-1
    K052859 AQUAMANTYS PUMP GENERATOR SYSTEM
    K032132 TISSUELINK FLOATING BALL MODEL 23-201-1
    K030380 TISSUELINK SEALING FORCEPS, MODEL 1 21-202-1
    K022532 TISSUELINK BIPOLAR FLOATING BALL DEVICE
    K020574 TISSUELINK BIPOLAR FLOATING BALL DEVICE
    K014260 TISSUELINK SOLID CYLINDER MONOPOLAR DEVICE
    K010662 MODIFICATION TO TISSUELINK MONOPOLAR FLOATING BALL
    K003005 TISSUELINK BIPOLAR FORCEPS
    Search all 12 clearances from Tissuelink Medical, Inc. →