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510(k) Data Aggregation

    K Number
    K182520
    Device Name
    Flexible Overtube
    Manufacturer
    Sumitomo Bakelite Co., Ltd
    Date Cleared
    2019-05-15

    (244 days)

    Product Code
    FED
    Regulation Number
    876.1500
    Why did this record match?
    Applicant Name (Manufacturer) :

    Sumitomo Bakelite Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Flexible Overtube is a device used in conjunction with a flexible endoscope for tissue or foreign body retrieval, and/or for endoscopic procedures requiring multiple endoscope intubations.
    Device Description
    Flexible Overtube™ provides an access for repeated insertion and withdrawal of an endoscope for tissue or foreign body retrieval, and/or for endoscopic procedures requiring multiple endoscope intubations. Prior to inserting an endoscope into a patient, the user passes the endoscope through Flexible Overtube™. Flexible Overtube™ is placed after the endoscope is inserted into the patient. The endoscope can be inserted and withdrawn through properly placed Flexible Overtube™.
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    K Number
    K190621
    Device Name
    SB Knife/Short type, SB Knife/Standard type, SB Knife/Jr type, SB Knife/Jr type - Long
    Manufacturer
    Sumitomo Bakelite Co., Ltd
    Date Cleared
    2019-04-23

    (43 days)

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

    Sumitomo Bakelite Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SB Knife® is a single-use sterile Electrosurgical Knife (Model Numbers: MD-47703 W, MD-47706 and MD-47703L). This device is designed to be used with Olympus and ERBE Electrosurgical monopolar HF generators, connectors and patient grounding plates to cut tissue including Zenker's diverticulum within the digestive tract using high-frequency current.
    Device Description
    The SB Knife® is a single-use sterile Electrosurgical Knife (Model Numbers: MD-47703 W, MD-47706 and MD-47703L).
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    K Number
    K152771
    Device Name
    SB Knife Jr type, SB Knife Short type, SB Knife Standard type, SB Knife Jr type - Long
    Manufacturer
    SUMITOMO BAKELITE CO., LTD.
    Date Cleared
    2016-06-17

    (266 days)

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

    SUMITOMO BAKELITE CO., LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SB Knife™ is a single-use sterile Electrosurgical Knife (Model Numbers: MD-47704, MD-47706 and MD-47703L). This device is designed to be used with Olympus and ERBE Electrosurgical monopolar HF generators, connectors and patient grounding plates to cut tissue within the digestive tract using high-frequency current.
    Device Description
    The SB Knife™ is a single-patient use EtO-sterilized hand-held device that connects to an external high frequency (HF) generator and is designed to be used with Olympus and ERBE Electrosurgical monopolar HF generators, connectors and patient grounding plates to cut tissue within the digestive tract using high-frequency current. Varying generator power, cycle and duration results in a control of these surgical capabilities. The SB Knives are designed to connect with Olympus and ERBE connectors and use the disposable or reusable Olympus or ERBE grounding plates and connecting cables intended for the generators. The device is not life supporting or life sustaining. It is designed as a short-term limited contact device (less than 24 hours), has no software, and has been certified to comply with IEC 60601-1 and IEC 60601-2-2 and IEC 60601-2-18 by UL Japan
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