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

    TISSUELINK AQUAMANTYS MALLEABLE BIPOLAR SEALER WITH LIGHT

    K Number: K073495 · Decision Jan 9, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    823
    Registration Numbers
    823
    Same Product Code
    2306
    Applicant Total
    12
    Review Days
    28

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    TISSUELINK AQUAMANTYS MALLEABLE BIPOLAR SEALER WITH LIGHT
    K Number
    K073495
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    878.4400
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Tissuelink Medical, Inc.
    Date Received
    December 12, 2007
    Decision Date
    January 9, 2008
    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

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (GEI), ordered by most recent decision date.

    Remanufactured LigaSure XP Maryland Jaw Sealer/Divider Without Nano-coating

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    CoolSeal Generator® (CSL-200-90)

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    NEUROMARK System (NMK00301)

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    LAP-iX2N

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    OsteoCool™ RF Ablation System; OsteoCool™ 2.0 RF Ablation System

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    MILAN System

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery
    View all

    Other Clearances by Tissuelink Medical, Inc.

    K Number Device Name
    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
    K010661 MODIFICATION TO TISSUELINK BIPOLAR FORCEPS
    K010662 MODIFICATION TO TISSUELINK MONOPOLAR FLOATING BALL
    K003005 TISSUELINK BIPOLAR FORCEPS
    Search all 12 clearances from Tissuelink Medical, Inc. →