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510(k) Data Aggregation

    K Number
    K150029
    Device Name
    Habib EUS RFA
    Manufacturer
    EMCISION, LTD.
    Date Cleared
    2015-06-24

    (167 days)

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

    EMCISION, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Habib EUS RFA 6700 is indicated for coagulation of soft tissue when used in conjunction with compatible radio frequency generator.
    Device Description
    The Habib EUS RFA 6700 is a catheter that is delivered during an EUS procedure, through 19 or 22 Gauge (G) endoscopic needles. The Habib EUS RFA 6700 is monopolar configuration and thus, must be used in conjunction with patient grounding pad. RF energy is produced by connecting the catheter to a compatible RF generator via an accessory cable. When attached to a generator, RF current is emitted from the exposed portion of the electrode and this current translates into ion agitation within the surrounding tissue, which is converted by friction into heat and induces cellular death by mans of coagulation necrosis.
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    K Number
    K083292
    Device Name
    HABIB ENDOHPB
    Manufacturer
    EMCISION, LTD.
    Date Cleared
    2009-06-10

    (212 days)

    Product Code
    KNS
    Regulation Number
    876.4300
    Why did this record match?
    Applicant Name (Manufacturer) :

    EMCISION, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Habib EndoHPB is intended to be used to assist in the coagulation of tissue during Endoscopic surgical procedures in the Gastro-intestinal Tract.
    Device Description
    The Habib EndoHPB is a bipolar radiofrequency (RF) device that consists of a catheter with 2 ring electrodes, introduced via an endoscope's biopsy channel and activated with bipolar RF energy. The Habib EndoHPB has an attached cable which connects the device to an RF Generator. The catheter is inserted into the gastrointestinal tract and the tissue is coagulated using the RF power. The Habib EndoHPB is designed for use in endoscopic procedures and is a single use sterile device.
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    K Number
    K080717
    Device Name
    HABIB HEXABLATE 10
    Manufacturer
    EMCISION, LTD.
    Date Cleared
    2008-03-27

    (14 days)

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

    EMCISION, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Habib Hexablate 10 is intended to be used to assist in coagulation of tissue during intraoperative surgical procedures.
    Device Description
    The Habib Hexablate 10 is a bipolar radiofrequency (RF) device that consists of a handle and an array of seven parallel electrodes which extend out from the handle. The electrode configuration consists of six electrodes in a ring and one electrode in the center of the ring. The Habib Hexablate 10 has an attached cable which connects the device to an RF Generator. The electrodes are inserted into tissue and the tissue is coagulated using RF power. The Habib Hexablate 10 is designed for use in surgery and is a single use device.
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    K Number
    K073687
    Device Name
    HABIB LAPAROSCOPIC HEXABLATE
    Manufacturer
    EMCISION, LTD.
    Date Cleared
    2008-01-09

    (12 days)

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

    EMCISION, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Habib Laparoscopic Hexablate is intended to be used to assist in coagulation of tissue during laparoscopic intraoperative surgical procedures
    Device Description
    The Habib Laparoscopic Hexablate is a bipolar radiofrequency (RF) device that consists of a handle, laparoscopic shaft and introducer and an array of seven parallel electrodes which extend out from the laparoscopic shaft. The electrode configuration consists of six electrodes in a ring and one electrode in the center of the ring. The Habib Laparoscopic Hexablate has an attached cable which connects the device to the Habib Hexablate Switch Unit and then to an RF Generator. The electrodes are inserted into tissue is coagulated using RF power. The Habib Laparoscopic Hexablate is designed for use in laparoscopic surgery and is a single use device.
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    K Number
    K072383
    Device Name
    HABIB ENDOBLATE
    Manufacturer
    EMCISION, LTD.
    Date Cleared
    2007-11-29

    (97 days)

    Product Code
    KNS, GAS
    Regulation Number
    876.4300
    Why did this record match?
    Applicant Name (Manufacturer) :

    EMCISION, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Habib Endoblate is a radiofrequency (RF) catheter which provides bipolar energy to enable the Endoscopist to cauterize and coagulate tissue in the gastrointestinal tract
    Device Description
    The Habib Endoblate is a bipolar radiofrequency (RF) device that consists of a catheter with 3 contact electrodes and 1 ring electrode, introduced via an endoscope's biopsy channel and activated with bipolar RF energy. The Habib Endoblate has an attached cable which connects the device to an RF Generator. The catheter is inserted into the gastrointestinal tract and the tissue is coagulated using the RF power. The Habib Endoblate is designed for use in endoscopy and is a single use sterile device.
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    K Number
    K072126
    Device Name
    HABIB VESEAL
    Manufacturer
    EMCISION, LTD.
    Date Cleared
    2007-10-02

    (61 days)

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

    EMCISION, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Habib™ VesCoag is a catheter intended to be used for the coagulation of blood vessels during general surgery.
    Device Description
    The Habib™ VesCoag is a bipolar radiofrequency (RF) device that consists of a catheter, wire connections, hub, Y connector and two ring electrodes are configured with two rings creating proximal and distal heating zones. The Habib™ VesCoag has an attached cable which connects the device to an RF Generator. The catheter is inserted into the vessel and the tissue is coagulated using the RF power. The Habib™ VesCoag is designed for use in surgery and in imaging/radiological procedures and is a single use sterile device.
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    K Number
    K071103
    Device Name
    HABIB HEXABLATE
    Manufacturer
    EMCISION, LTD.
    Date Cleared
    2007-06-27

    (69 days)

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

    EMCISION, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Habib Hexablate is intended to be used to assist in coagulation of tissue during intraoperative surgical procedures.
    Device Description
    The Habib Hexablate is a bipolar radiofrequency (RF) device that consists of a handle and an array of seven parallel electrodes which extend out from the handle. The electrode configuration consists of six electrodes in a ring and one electrode in the center of the ring. The Habib Hexablate has an attached cable which connects the device to the Habib Hexablate Switch Unit and then to an RF Generator. The electrodes are inserted into tissue is coagulated using RF power. The Habib Hexablate is designed for use in surgery and is a single use device.
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    K Number
    K051420
    Device Name
    HABIB 4X
    Manufacturer
    EMCISION, LTD.
    Date Cleared
    2005-08-15

    (75 days)

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

    EMCISION, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Habib 4X is intended to be used to assist in coagulation of tissue during intraoperative surgical procedures.
    Device Description
    Not Found
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