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510(k) Data Aggregation

    K Number
    K042160
    Device Name
    SONOSURG TROCAR
    Manufacturer
    AOMORI OLYMPUS CO., LTD.
    Date Cleared
    2005-01-25

    (168 days)

    Product Code
    LFL
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    AOMORI OLYMPUS CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    1) Indications for Use of SonoSurg Trocar This instrument has been designed to be used with the SonoSurg generator (SonoSurg-G2) and is inserted into the body cavity wall by means of ultrasonic waves under endoscopic surgery in order to coagulate and cut soft tissue as well as to place a trocar tube within the body cavity wall. 2) Indications for Use of SonoSurg G-2 Set This instrument has been designed to be used with the SonoSurg transducers and the SonoSurg ultrasonic surgical instruments for soft tissue cutting and coagulation for laparoscopic and general (open) surgery in intraabdominal and obstetric/gynecologic procedures, and endoscopic and general surgery in ENT (Ears, Nose, Throat), thoracic, and urologic procedures. This instrument may also be combined with the SonoSurg Irrigation Unit (SonoSurg-IU). Please refer to the SonoSurg-IU instruction manual to review the intended use of this combined system. This instrument may also be combined with the SonoSurg Trocar. Please refer to the SonoSurg Trocar instruction manual to review the intended use of this combined system.
    Device Description
    The SonoSurg Trocar is an Ultrasonic trocar for endoscopic surgery which enable the puncture and cutting of the abdominal wall with tissue coagulation by means of ultrasonic vibration. SonoSurg Trocar is composed of two sections, the SonoSurg Trocar and the Olympus SonoSurg Generator SonoSurg-G2. The SonoSurg Trocar is composed of a trocar transducer, dilator, valve, trocar tube, insertion sheath, probe, and Olympus SonoSurg Generator SonoSurg-G2, which provides ultrasonic vibration to the SonoSurg Trocar.
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    K Number
    K041566
    Device Name
    SONOSURG ULTRASONIC SURGICAL SYSTEM
    Manufacturer
    AOMORI OLYMPUS CO., LTD.
    Date Cleared
    2004-09-08

    (90 days)

    Product Code
    LFL
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    AOMORI OLYMPUS CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SonoSurg Ultrasonic Surgical System is indicated for use in surgical procedure in neurosurgery where dissection, fragmentation, emulsification and aspiration of soft tissue are desirable. This system consists of the SonoSurg Generator (SonoSurg-G2 set), SonoSurg Irrigation Unit (SonoSurg-IU), SonoSurg Transducer (SonoSurg-T2L-MS), and SonoSurg ultrasonic surgical instruments, and is designed to be used with a separate surgical suction source. Do not use this system for any purpose other than its intended use.
    Device Description
    The subject SonoSurg is an ultrasonic surgical device designed to be used with Generator Irrigation Unit and Transducer and ultrasonic surgical instruments to dissect, fragment, enulsify and aspirate tissue in the neurosurgical field. This system consists of the SonoSurg Senerator (SonoSurg-G2 set), SonoSurg Imigation Unit (SonoSurg-IU), SonoSurg-Transducer(SonoSurg-T2L-MS), and SonoSurg ultrasonic surgical instruments, and is designed to be used with a separate surgical suction source.
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    K Number
    K033333
    Device Name
    SINGLE USE 3-LUMEN BALLOON CATHETER, MODELS B-230Q-A AND B-230Q-B
    Manufacturer
    AOMORI OLYMPUS CO., LTD.
    Date Cleared
    2003-11-14

    (29 days)

    Product Code
    FGE, KOG
    Regulation Number
    876.5010
    Why did this record match?
    Applicant Name (Manufacturer) :

    AOMORI OLYMPUS CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    These instruments have been designed to be used with Olympus endoscopes to inject contrast media into the biliary or pancreatic tract. They can also be used for retrieval of biliary or pancreatic stones.
    Device Description
    The subject device(s) is a balloon catheter that has a triple-lumen catheter and a multiple sizing balloon with pre-measured syringes, to be used in accordance with Intended use of the device. These functions ensure smoother passage of the guidewire and injection of the contrast media without removing the guidewire, and enable to inflate one balloon to 3 different sizes.
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    K Number
    K031523
    Device Name
    OLYMPUS ULTRASONIC SURGICAL SYSTEM
    Manufacturer
    AOMORI OLYMPUS CO., LTD.
    Date Cleared
    2003-10-01

    (139 days)

    Product Code
    LFL
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    AOMORI OLYMPUS CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    OLYMPUS Ultrasonic Surgical System has been designed to be used with the Olympus SonoSurg generator Set (SonoSurg-G2 Set) and an electrosurgical unit to cut and coagulate soft tissue for laparoscopic and intraabdominal procedures in general (open) surgery. It is also designed to cut and coagulate soft tissue for open and endoscopic procedures in urologic surgery.
    Device Description
    The Olympus Ultrasonic Surgical System is composed of three sections, (1), (2), and (3). - (1) Olympus SonoSurg Scissors 5mm O.D. T3050" or "Olympus SonoSurg Long Hook 5mm O.D. T3060" or "Olympus SonoSurg Long Scissors 5mm O.D. T3070", or "Olympus SonoSurg Scissors 5mm O.D., HF Series. - (2) Olympus SonoSurg Transducer SonoSurg-T2H. - (3) Olympus SonoSurg Generator Set SonoSurg-G2 Set (SonoSurg-G2, MAJ-51). This device is intended to cut and coagulate soft tissue for open and endoscopic procedures in urologic surgery.
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    K Number
    K031710
    Device Name
    OLYMPUS ULTRASONIC SURGICAL SYSTEM
    Manufacturer
    AOMORI OLYMPUS CO., LTD.
    Date Cleared
    2003-08-29

    (88 days)

    Product Code
    LFL
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    AOMORI OLYMPUS CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Olympus Ultrasonic System has been designed to be used with the Olympus SonoSurg Generator Set (SonoSurg-G2 Set) and an electrosurgical unit to cut and coagulate soft tissue for laparoscopic and intrabdominal procedures in general(open) surgery. Also it has been designed to be used with them to cut and coagulate soft tissue for open and endoscopic procedures in thoracic surgery.
    Device Description
    The Olympus Ultrasonic Surgical System is composed of three sections, (1), (2), and (3). - (1) Olympus SonoSurg Scissors 5mm O.D. T3050" or "Olympus SonoSurg Long Hook 5mm O.D. T3060" or "Olympus SonoSurg Long Scissors 5mm O.D. T3070", or "Olympus SonoSurg Scissors 5mm O.D., HF Series. - (2) Olympus SonoSurg Transducer SonoSurg-T2H. - (3) Olympus SonoSurg Generator Set SonoSurg-G2 Set (SonoSurg-G2, MAJ-51). This device is intended to cut and coagulate soft tissue for open and endoscopic procedures in thoracic surgery.
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    K Number
    K021672
    Device Name
    PANCREATIC DRAINAGE TUBE
    Manufacturer
    AOMORI OLYMPUS CO., LTD.
    Date Cleared
    2003-04-16

    (330 days)

    Product Code
    FGE
    Regulation Number
    876.5010
    Why did this record match?
    Applicant Name (Manufacturer) :

    AOMORI OLYMPUS CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This instrument has been designed to be used with Olympus endoscopes for Endoscopic Pancreatic Drainage. The Drainage Tube is not intended to be permanently implanted in the patient. The Drainage Tube is intended for short-term implantation. The Drainage Tube is also available as a kit, which includes accessories to aid in the placement of the Drainage Tube.
    Device Description
    Pancreatic Drainage Tube has been designed to be used with Olympus endoscopes for Endoscopic Pancreatic Drainage. The instrument consists of the Drainage Tube, and Insertion Kit and Guidewire. The Drainage Tube is not intended to be permanently implanted in the patient. The drainage Tube is intended for short-term implantation.
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    K Number
    K022446
    Device Name
    MUCUS COLLECTION PROBE, MODELS BC-401C & BC-402C
    Manufacturer
    AOMORI OLYMPUS CO., LTD.
    Date Cleared
    2003-03-28

    (246 days)

    Product Code
    EOQ
    Regulation Number
    874.4680
    Why did this record match?
    Applicant Name (Manufacturer) :

    AOMORI OLYMPUS CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The subject devices are designed to be used with an Olympus bronchoscope for the collection of bronchial secretions in the tracheobronchial tree. Bronchial fluids absorbed onto the fiber tip of the collection probe are subsequently analyzed for biochemical constituents.
    Device Description
    Mucus Collection Probes, BC-401C and BC-402C, have been designed to be used with an Olympus endoscope to collect bronchial secretions in the tracheobronchial tree. Bronchial fluids absorbed onto the fiber tip of the collection probe are subsequently analyzed for biochemical constituents. Single use.
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