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510(k) Data Aggregation

    K Number
    K103775
    Device Name
    PEAK SUCTION COAGULATOR
    Manufacturer
    PEAK SURGICAL, INC.
    Date Cleared
    2011-05-27

    (151 days)

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

    PEAK SURGICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Suction Coagulator is a single use electrode attachment, designed to be attached to the PEAK PlasmaBlade TnA handpiece and is intended for use in surgical procedures, such as general and otolaryngology (ENT) surgery procedures, where the coagulation of tissue and suction of fluids are desired. It is not indicated for the removal of tonsils and adenoids.
    Device Description
    The PEAK Suction Coagulator consists of of an active suction lumen, a bendable shaft, and a finger grip for attachment to the TnA handpiece and is to be used for the coagulation of tissues and aspiration of fluids during electrosurgical procedures. The device is activated by pressing the coag button (blue) on the TnA handpiece.
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    K Number
    K102709
    Device Name
    PEAK PLASMABLADE PLUS TISSUE DISSECTION DEVICE
    Manufacturer
    PEAK SURGICAL, INC.
    Date Cleared
    2010-12-17

    (88 days)

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

    PEAK SURGICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The PEAK PlasmaBlade® PLUS Tissue Dissection Device is indicated for cutting and coagulation of soft tissue during General, Plastic and Reconstructive (including but not limited to skin incisions and development of skin flaps), ENT, Gynecologic, Orthopaedic, Arthroscopic, Spinal and Neurological surgical procedures.
    Device Description
    The PEAK PlasmaBlade® PLUS consists of a single insulated bendable blade, telescoping shaft that can be configured in both standard and extended length and a handle with integrated controls and cable. The finger grip incorporates a suction lumen for the evacuation of smoke and fluids. A ball electrode attaches to the finger grip to allow a broader application of energy. The PlasmaBlade PLUS is an addition to the PEAK PlasmaBlade Family of Tissue Dissection devices which include the PlasmaBlade 4.0, PlasmaBlade Needle, PlasmaBlade EXT and PlasmaBlade 3.0S.
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    K Number
    K102029
    Device Name
    PEAK PULSAR II GENERATOR MODEL PS100-102
    Manufacturer
    PEAK SURGICAL, INC.
    Date Cleared
    2010-12-16

    (150 days)

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

    PEAK SURGICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The PEAK Surgery System is indicated for cutting and coagulation of soft tissue during General, Plastic and Reconstructive (including but not limited to skin incisions and development of skin flaps), ENT, Gynecologic, Orthopaedic, Arthroscopic, Spinal and Neurological surgical procedures.
    Device Description
    The PEAK Surgery System consists of the PULSAR II Generator, PEAK PlasmaBlade Tissue Dissection Devices and an optional wireless footswitch. The PULSAR II Generator is a microcontroller based, isolated output, electrosurgical unit that has been designed to produce monopolar RF energy for cutting and coagulation during surgery. The PULSAR II Generator is used with the PEAK PlasmaBlade Tissue Dissection Devices which are single use, sterile handpieces for monopolar energy delivery. The PlasmaBlade Tissue Dissection Devices consist of an insulated blade electrode, rotating shaft, handle with integrated controls and a cable. An optional footswitch may be used to operate the system in lieu of the controls on the PlasmaBlade handpieces.
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    K Number
    K093695
    Device Name
    PEAK PLASMABLADE 3.OS TISSUE DISSECTION DEVICE
    Manufacturer
    PEAK SURGICAL, INC.
    Date Cleared
    2010-04-13

    (134 days)

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

    PEAK SURGICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The PEAK PlasmaBlade® 3.0S Tissue Dissection Device is indicated for cutting and coagulation of soft tissue during General, Plastic and Reconstructive (including but not limited to skin incisions and development of skin flaps), ENT, Gynecologic, Orthopaedic, Arthroscopic, Spinal and Neurological surgical procedures.
    Device Description
    The PEAK PlasmaBlade® 3.0S consists of a single insulated bendable blade. telescoping shaft that can be configured in both standard and extended length and a handle with integrated controls and cable. The finger grip also incorporates a suction lumen for the evacuation of smoke and fluids. The PlasmaBlade 3.0S is an addition to the PEAK PlasmaBlade Family of Tissue Dissection devices which include the PlasmaBlade 4.0, PlasmaBlade Needle, and PlasmaBlade EXT.
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    K Number
    K083415
    Device Name
    PEAK PLASMABLADE TNA TONSIL AND ADENOID TISSUE DISSECTION DEVICE
    Manufacturer
    PEAK SURGICAL, INC.
    Date Cleared
    2009-06-05

    (199 days)

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

    PEAK SURGICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The PEAK PlasmaBlade™ TnA Tonsil and Adenoid Tissue Dissection Device is only indicated for cutting and coagulation of soft tissue during otolaryngology (ENT) surgery including adenoidectomy and tonsillectomy (Pharyngeal, Tubal, Palatine).
    Device Description
    The PEAK PlasmaBlade TnA Tonsil and Adenoid Tissue Dissection Device consists of a handpiece with integrated controls and cable, a shaft with a suction cannula, and two interchangeable tips. The tonsil tip consists of a curved and tapered insulated blade electrode with an opening in the center to allow for the evacuation of smoke and fluids. The adenoid tip consists of a flat, straight insulated blade electrode housed in a plastic tip with a bendable suction lumen that allows for the evacuation of tissue, fluids and smoke. Both tips connect to the suction cannula of the handpiece.
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    K Number
    K082786
    Device Name
    PULSAR GENERATOR, PEAK PLASMABLADE; 4.0, NEEDLE, AND EXT TISSUE DISSECTION DEVICES
    Manufacturer
    PEAK SURGICAL, INC.
    Date Cleared
    2008-12-03

    (71 days)

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

    PEAK SURGICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The PEAK Surgery System is indicated for cutting and coagulation of soft tissue during General, Plastic and Reconstructive (including but not limited to skin incisions and development of skin flaps), ENT, Gynecologic, Orthopaedic, Arthroscopic, Spinal and Neurological surgical procedures.
    Device Description
    The PEAK Surgery System consists of the PULSAR Generator, PEAK PlasmaBlade Tissue Dissection Devices, and an optional wireless foot pedal. The PULSAR Generator is a microcontroller based, isolated output, electrosurgical unit that has been designed to produce monopolar and bipolar RF energy for cutting and coagulation during surgery. The PULSAR Generator is used with the PEAK PlasmaBlade Tissue Dissection Devices, which are single use, sterile handpieces for monopolar energy delivery. The PEAK PlasmaBlade Tissue Dissection Devices consists of an insulated blade electrode, rotating bendable shaft, handle with integrated controls, and a cable. An optional footswitch may be used to operate the system in lieu of the controls on the PlasmaBlade handpieces.
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    K Number
    K073057
    Device Name
    PULSAR GENERATOR, MODEL PS100-100, AND PEAK PLASMABLADE TISSUE DISSECTION DEVICE, MODEL PS200-040
    Manufacturer
    PEAK SURGICAL, INC.
    Date Cleared
    2008-07-22

    (266 days)

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

    PEAK SURGICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The PULSAR Generator with the PEAK PlasmaBlade Tissue Dissection Device is intended to be used for cutting and coagulation of soft tissue during surgical procedures.
    Device Description
    The PULSAR Generator is a microcontroller based, isolated output, electrosurgical unit that has been designed to produce monopolar and bipolar RF energy for cutting and coagulation during surgery. The PULSAR Generator is used with the PEAK PlasmaBlade Tissue Dissection Device, which is a single use, sterile handpiece for monopolar energy delivery. The PEAK PlasmaBlade Tissue Dissection Device consists of an insulated blade electrode, rotating bendable shaft, handle with integrated controls, and a cable. An optional footswitch may be used to operate the system in lieu of the controls on the PlasmaBlade handpiece.
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