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510(k) Data Aggregation

    K Number
    K132974
    Device Name
    AQUAMANTYS 2.3 BIPOLAR SEALER, EVS 4.0 EPIDURAL VEIN SEALER, MINI EVS 3.4 EPIDURAL VEIN SEALER, SBS 5.0 SHEATHED BIPOLAR
    Manufacturer
    MEDTRONIC ADVANCED ENERGY, LLC
    Date Cleared
    2013-12-03

    (71 days)

    Product Code
    GEI
    Regulation Number
    878.4400
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDTRONIC ADVANCED ENERGY, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Aquamantys 2.3 Bipolar Sealer is a sterile, single-use, bipolar electrosurgical device intended to be used in conjunction with the Aquamantys Pump Generator for delivery of RF energy and saline for hemostatic sealing and coagulation of soft tissue and bone at the operative site. It is intended for, but not limited to orthopaedic, neurosurgical, spine, thoracic, and open abdominal surgery. The device is not intended for contraceptive tubal coagulation (permanent female sterilization). The Aquamantys Epidural Vein Sealer is a sterile, single-use bipolar electrosurgical device intended to be used in conjunction with the Aquamantys Pump Generator for delivery of RF energy and saline for hemostatic sealing and coagulation of soft tissue and bone at the operative site. It is intended for, but not limited to orthopaedic, neurosurgical, spine, endoscopic procedures, abdominal and thoracic surgery, and epidural vein sealing during surgery. The device is not intended for contraceptive tubal coagulation (permanent female sterilization). The Aquamantys SBS 5.0 Sheathed Bipolar Sealer is a sterile, single-use bipolar electrosurgical device intended to be used in conjunction with the Aquamantys Pump Generator for delivery of RF energy and saline for hemostatic sealing and coagulation of soft tissue and bone at the operative site. It is intended for, but not limited to orthopaedic, neurosurgical, spine, endoscopic procedures, abdominal and thoracic surgery, and epidural vein sealing during surgery. The device is not intended for contraceptive tubal coagulation (permanent female sterilization).
    Device Description
    The Aquamantys Bipolar Sealer is a sterile, single-use bipolar device. The device employs radio-frequency (RF) energy and saline irrigation for hemostatic sealing and coagulation. The device is equipped with a dual electrode tip. Saline and electrical lines exit the opposite end of the handpiece from the electrodes. The handpiece is equipped with an on-off button that simultaneously activates both RF and saline flow. A saline fluid delivery line is provided with the device, and includes a section of pump tubing and drip chamber or spike. The three-pin electrical connector is designed to be plugged into the Aquamantys Pump Generator.
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    K Number
    K123201
    Device Name
    AQUAMANTYS ENDO DBS 8.7 DISSECTING BIPOLAR SEALER
    Manufacturer
    MEDTRONIC ADVANCED ENERGY, LLC
    Date Cleared
    2013-01-10

    (90 days)

    Product Code
    GEI
    Regulation Number
    878.4400
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDTRONIC ADVANCED ENERGY, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Aquamantys Endo DBS 8.7 Dissecting Bipolar Sealer is a single use, sterile. bipolar device intended to be used in conjunction with the Aquamantys Pump Generator for delivery of radio-frequency (RF) energy and saline for blunt dissection and for haemostatic sealing and coagulation of soft tissue at the operative site. It is intended for. but not limited to, abdominal, and thoracic surgery, endoscopic, laparoscopic, and thoracoscopic procedures. The device is not intended for contraceptive tubal coagulation (permanent female sterilization).
    Device Description
    The Aquamantys Endo DBS 8.7 device is a handheld "wand-like" disposable that, when connected to the Aquamantys Pump Generator, uses bipolar radio-frequency energy concurrent with saline for hemostatic sealing and coagulation. The device is equipped with dual electrodes at the distal tip. Saline and electrical lines enter from the opposite end (proximal end) of the device's hand piece from the distal electrodes. The device's hand piece is equipped with a blue button that activates bipolar RF energy concurrent with saline flow for blunt dissection and for hemostatic sealing and coagulation. The long, stainless steel shaft allows for the device to be used in laparoscopic, endoscopic and thoracoscopic procedures. A saline fluid delivery line is provided with the device, which includes a drip chamber/spike for insertion into saline bags. The proposed device connects to the Aquamantys Pump Generator using a three-pronged connector.
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    K Number
    K120909
    Device Name
    EC 2.7 ENDOSCOPIC CUTTER
    Manufacturer
    MEDTRONIC ADVANCED ENERGY, LLC
    Date Cleared
    2012-11-02

    (221 days)

    Product Code
    GEI
    Regulation Number
    878.4400
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDTRONIC ADVANCED ENERGY, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The EC 2.7 Endoscopic Cutter is a single use electrosurgical instrument designed to be used with flexible bronchoscopes and qualified electrosurgical units. It is indicated for cutting of soft tissue obstructions in upper airways and tracheobronchial tree, and provision of electrosurgical hemostasis during such procedures.
    Device Description
    The EC 2.7 Endoscopic Cutter is a disposable, single-patient-use monopolar RF (radio-frequency) surgical endotherapy device intended to be inserted through the working channel of a flexible bronchoscope. The EC 2.7 Endoscopic Cutter is terminally sterilized via ETO. It is comprised of a separately packaged, cylindrically shaped, disposable monopolar cutting and coagulation electrode affixed to the distal end of a polymeric, flexible multi lumen shaft , and a separately packaged, single-patient-use, electrical adaptor with cabling, intended for connection to the monopolar output port of a Covidien® Corporation, ValleyLab™ Force FX™ or FX-C Electrosurgical Generator. The ValleyLab™ Force FX™ was cleared to market via 510(k) K944602.
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