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510(k) Data Aggregation

    K Number
    K222173
    Device Name
    Saneso Lens Wash Bottle Assembly (SAN-LWB-A)
    Manufacturer
    Date Cleared
    2023-02-27

    (221 days)

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

    Saneso, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Saneso Lens Wash Bottle Assembly (SAN-LWB-A) is intended to be used with FDA-cleared Saneso endoscopes. It facilitates the following: 1. Sterile water for lens wash function 2. Air / CO2 for luminal insufflation function
    Device Description
    The Saneso Lens Wash Bottle Assembly is intended to be used with Saneso endoscopes. It facilitates the following: - Sterile water for lens wash function 1. - 2. Air / CO2 for luminal insufflation function Saneso lens wash & insufflation system is divided into proximal and distal sections: Proximal Section: It comprises the Lens Wash Bottle Assembly and terminates at its connection with the air/water port on the endoscope. It consists of the lens wash bottle, lens wash bottle cap, airline, water line, CO2 line, and air/water connector. This section is the non-patient contacting portion of the system and is covered in this submission. Distal Section: It starts at the air/water port and terminates at the air/water nozzles on the distal end of the endoscope. It consists of the air/water valve, air/water valve, air/water channel, and the lens wash nozzles, which are all located in the endoscope. This section is the patient contacting portion of the system and is part of the Saneso endoscopes, which is FDA 510k approved (K210052).
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