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510(k) Data Aggregation

    K Number
    K202727
    Device Name
    Peregrine Endoscopy System
    Manufacturer
    3NT Medical Ltd.
    Date Cleared
    2021-07-23

    (309 days)

    Product Code
    EOB
    Regulation Number
    874.4760
    Why did this record match?
    Applicant Name (Manufacturer) :

    3NT Medical Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Peregrine Endoscopy System is intended to visualize the internal cavities of the ear, airways, nose and sinus cavities during diagnostic and therapeutic endoscope procedures.
    Device Description
    The Peregrine Endoscopy System is a single-use flexible ENT (ear, nose & throat) endoscope (provided sterile) which allows the user to steer through the anatomy and visualize it. The device is used in patients in whom endoscopic evaluation of, or intervention in, the ear, airways, nose, and sinus cavities is indicated. The modified Peregrine endoscopy system consists of: - A Single-use Endoscope - includes a distal CMOS imager, an illumination source, and a working channel which enables irrigation and suction. The endoscope is provided sterile. The multi-use handle and the endoscope attachment cable, which were separate components in the cleared 3NT Endoscopy System, are now an integral part of the single-use endoscope, thus eliminating all multi-use components from the system. - A Video Console (formerly named Camera Control Unit, or CCU) which includes a video board and a tablet-based display, connects to the endoscope through the endoscope cable to receive video images from the endoscope and display them.
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    K Number
    K192305
    Device Name
    Colibri Endoscopy System
    Manufacturer
    3NT Medical Ltd.
    Date Cleared
    2020-02-27

    (188 days)

    Product Code
    EOB
    Regulation Number
    874.4760
    Why did this record match?
    Applicant Name (Manufacturer) :

    3NT Medical Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Colibri Endoscopy System is intended to visualize the internal cavities of the ear, airways, nose and sinus cavities during diagnostic and therapeutic endoscope procedures.
    Device Description
    The Colibri Endoscopy System is a single-use ENT (ear, nose & throat) endoscope (provided sterile under EtO sterilization) which allows the user to steer through the anatomy and visualize it. The device is used in patients in whom endoscopic evaluation of, or intervention in, the ear, airways, nose, and sinus cavities is indicated. The Colibri endoscopy system consists of: A Single-use Endoscope includes a distal CMOS imager, an LED for illumination, and an add-on working channel which enables suction. The endoscope is provided sterile. The multi-use handle and the endoscope attachment cable, which were separate components in the cleared 3NT Endoscopy System, are now an integral part of the single-use endoscope, thus eliminating all multi-use components from the system. A Video Console (formerly named Camera Control Unit, or CCU) which includes a video board and a tablet-based display, connects to the endoscope through the endoscope cable to receive video images from the endoscope and display them.
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    K Number
    K181838
    Device Name
    Sinusway Dilation System
    Manufacturer
    3NT Medical Ltd.
    Date Cleared
    2018-12-20

    (163 days)

    Product Code
    LRC
    Regulation Number
    874.4420
    Why did this record match?
    Applicant Name (Manufacturer) :

    3NT Medical Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Sinusway Dilation System is intended to access and treat the frontal, maxillary and sphenoid sinuses in sinus procedures in adults using a trans-nasal approach, by dilation and displacement of the anatomic structures along the sinus drainage pathways.
    Device Description
    Sinusway Dilation System combines the tissue expansion effect of balloon dilation with the features of a curved sinus seeker, and by that allows the user to track the dilation device into the sinus drainage pathways. The shape of the distal end of the dilation system can be changed by inserting pre-shaped seekers into it. The system includes: 1. A Dilation Kit (Single use, provided sterile) consists of the following components: a. A Dilation Device includes an inflatable balloon at its distal end and connects to the inflation device at its proximal end. b. Three interchangeable pre-shaped Seekers (also referred to as stylets). c. An Inflation Device connects to the dilation device and inflates it while providing visual and tactile pressure indication. All Dilation Kit components are disposed of at the end of the procedure. 2. A Holder (re-processible and auto-clavable) - holds the components of the Dilation Kit in place and locks them, allowing the user to operate the dilation tool.
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    K Number
    K162916
    Device Name
    3NT endoscopy system
    Manufacturer
    3NT Medical Ltd.
    Date Cleared
    2017-02-24

    (130 days)

    Product Code
    EOB
    Regulation Number
    874.4760
    Why did this record match?
    Applicant Name (Manufacturer) :

    3NT Medical Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The 3NT endoscopy system is intended to visualize the internal cavities of the ear, airways, nose and sinus cavites during diagnostic and therapeutic endoscope procedures.
    Device Description
    3NT endoscopy system is a single-use flexible ENT (ear, nose & throat) endoscope (provided sterile) which allows the user to steer through the anatomy and visualize it. 3NT endoscopy system includes: 1. A Single-use flexible endoscope (provided sterile) includes a distal tip CMOS imager and an integrated working channel which allows irrigation through a single channel. It is the only part that comes in contact with the patient and is disposed of at the end of the procedure. 2. A Multi-use handle accessory (re-processible and auto-clavable) engages the single-use endoscope component and allows the user to mechanically control its articulation through dedicated levers. 3. A Camera control unit (CCU) includes a video processor and a white LED light source. The CCU includes an attachment cable which connects to the single-use endoscope, receives video images from the endoscope, and delivers LED light to the endoscope.
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