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510(k) Data Aggregation

    K Number
    K091838
    Device Name
    OBP SELF SEALING ENDOSCOPIC SEAL WITH LUER LOCK
    Manufacturer
    OBP MEDICAL
    Date Cleared
    2009-12-04

    (165 days)

    Product Code
    HIH, HET, ODC
    Regulation Number
    884.1690
    Why did this record match?
    Applicant Name (Manufacturer) :

    OBP MEDICAL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The OBP Self-Sealing Endoscopic Seal is a single use, sterile endoscopic introducer seal. It is affixed to the proximal port of the endoscope working channel. It prevents efflux of distention fluid when the channel is not being used or when instruments are passed through the working channel of the endoscope. The seal may be used with following types of endoscopes: hysteroscope, laparoscope, cystoscope, and colonoscope.
    Device Description
    The OBP Self-Sealing Endoscopic Seal is a single use, sterile endoscopic introducer seal. It is affixed to the proximal port of the endoscope working channel. It prevents efflux of distention fluid when the channel is not being used or when instruments are passed through the working channel of the endoscope. The seal may be used with following types of endoscopes: hysteroscope, laparascope, cystoscope, and colonoscope. The seal comes with 4 different size channels to accommodate different size instruments. They are: 0.6mm, 1.2mm, 1.6mm, and 2.0mm. The 4 different seals are marked with different colored bands: yellow (0.6mm seal), light pink (1.2mm seal), green (1.6mm seal), and blue (2.0mm seal).
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