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510(k) Data Aggregation

    K Number
    K201151
    Device Name
    O-Mec 690 Series Laparoscopes
    Manufacturer
    OMEC Medical, Inc.
    Date Cleared
    2020-06-22

    (54 days)

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

    OMEC Medical, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The O-Mec Laparoscopes 690 Series (Models, 90-331000H, 690-300500H, 690-300500H, are intended to be used by surgeons in diagnostic and therapeutic procedures. Laparoscopic minimally invasive procedures are performed in the abdominal cavity by means of small skin punctures that allow the insertion of the laparoscope and laparoscopic instruments.
    Device Description
    O-Mec laparoscopes 690 Series Models 690- 331000H, 690-331030H, 690-300500H, 690-300530H are rigid endoscopes that are used to view a patient's internal anatomy for examination, diagnosis and therapy during laparoscopic procedures. An endoscope is a slender, tubular optical instrument used as a viewing system for examining an inner part of the body. The inside of the endoscope contains a series of lenses that transmit the endoscopic image, which is illuminated by an external light source. O-Mec laparoscopes 690 Series Models 690- 331000H, 690-331030H, 690-300500H, 690-300530H are available in two sizes: 5mm or 10mm diameters, with either 0° or 30° directions of view. O-Mec laparoscope provides a high definition image and can correct chromatic aberration in the 400-900nm wavelength range. O-Mec laparoscopes 690 Series Models 690- 331000H, 690-331030H, 690-300500H, 690-300530H are delivered non-sterile and are reusable and fully autoclavable. O-Mec laparoscopes must be cleaned according to the Instructions of Use before each use.
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