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510(k) Data Aggregation

    K Number
    K151308
    Device Name
    Schoelly Nephroscope Set, Schoelly Ultra-Mini Nephroscope Set
    Manufacturer
    SCHOELLY FIBEROPTIC, GMBH
    Date Cleared
    2016-02-09

    (267 days)

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

    SCHOELLY FIBEROPTIC, GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Schoelly Nephroscope Set is used for the disintegration and removal / extraction of kidney stones. The stones are removed, under endoscopic control, through percutaneous passages, in conjunction with intracorporeal pneumatic, ultrasound, electrohydraulic or laser lithotripters. The Schoelly Ultra-Mini Nephroscope Set is used for the disintegration and removal / extraction of kidney stones. The stones are removed, under endoscopic control, through percutaneous passages, in conjunction with laser lithotripters.
    Device Description
    The proposed Schoelly Nephroscope Family comprises two different application sets: One set for Percutaneous Nephrolithotomy (PCNL) with the trade name "Schoelly Nephroscope Set'' and one set for Mini PCNL with the trade name "Ultra-Mini Nephroscope Set". Both sets include a rigid, reusable endoscope (nephroscope) that is used in conjunction with a commercially available and approved light guide, light source. video camera, monitor, and printer. Light guide, light source, video camera, monitor, and printer are not included in the scope of delivery and are further not within the scope of this application. In case of both sets, the nephroscope is accompanied by corresponding accessories to allow for access and passage of the nephroscope and retrieval instruments and for irrigation. Those include compatible endoscopic sheaths, obturators, and bridges. The Schoelly Nephroscope Set and the Schoelly Ultra-Mini Nephroscope set are delivered in non-sterile conditions and have already obtained CE mark.
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    K Number
    K132009
    Device Name
    CMOS VIDEO NASOPHARYNGOSCOPE SYSTEM
    Manufacturer
    SCHOELLY FIBEROPTIC, GMBH
    Date Cleared
    2014-04-09

    (282 days)

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

    SCHOELLY FIBEROPTIC, GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Schoelly CMOS Video Nasopharyngoscope System may only be used by persons with an appropriate medical qualification and who are acquainted with the rhinoflaryngoscopic technique. The endoscope is used for endoscopic diagnosis within the nasal lumens and airway anatomy, and is intended to provide visualization via a video monitor.
    Device Description
    The Schoelly CMOS Video Nasopharyngoscope System consists of a flexible and steerable endoscope and a camera control unit (CCU) for regulation of light intensity and connection to a monitor, PC, medical video recorder or printer for image display or image documentation. The endoscope has outer surfaces mainly made from plastic. The endoscope handle incorporates a control lever to bend the distal tip and an integrated LED light source. Light is transmitted through fiberoptic bundles illuminating the anatomy under investigation. The video signal is captured by a CMOS imaging sensor located at the tip of the endoscope shaft and transferred to the CCU. The endoscope further incorporates a ventilation system to protect the shaft. The exhaust valve at the endoscope handle can further be used for leakage testing. For this purpose the system is accompanied by a leakage tester and accessories. The Schoelly CMOS Video Nasopharyngoscope System is delivered in a non-sterile condition and is already CE marked.
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    K Number
    K992362
    Device Name
    FLEXISCOPE IQ 101
    Manufacturer
    SCHOELLY FIBEROPTIC, GMBH
    Date Cleared
    1999-08-05

    (21 days)

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

    SCHOELLY FIBEROPTIC, GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Scholly Flexiscope IQ 101 is indicated for video visualization of sites in conjunction with endoscopic devices.
    Device Description
    Not Found
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    K Number
    K984641
    Device Name
    FLEXISCOPE OPTOMODUL
    Manufacturer
    SCHOELLY FIBEROPTIC, GMBH
    Date Cleared
    1999-03-29

    (88 days)

    Product Code
    EIA, DEC
    Regulation Number
    872.6640
    Why did this record match?
    Applicant Name (Manufacturer) :

    SCHOELLY FIBEROPTIC, GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Flexiscope Optomodul is indicated for use during dental in the country bear when a video image is desired. The Flexiscope Optomodul Is Indreason 2007 - 100 mm a video image is desired.
    Device Description
    Not Found
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