BEUDAMED
    Product Code: SEW FDA class 2 21 CFR 880.6994

    Automated Endoscope Channel Cleaner

    General Hospital
    View on FDA
    510(k)s
    2
    FEI Numbers
    2
    Registration Numbers
    2
    Unique Applicants
    1
    Years Active
    1

    Basic Information

    Product Code
    SEW
    Device Class
    FDA class 2
    Regulation Number
    880.6994
    Medical Specialty
    General Hospital
    Review Panel
    HO
    Submission Type
    1

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    Definition

    An automated endoscope channel cleaner is a device intended to replace all or a portion of manual cleaning of internal passages and ports of compatible reusable flexible endoscopes. Cleaning is conducted using an agent that exerts physical force (e.g., friction) on single or multiple channels of compatible endoscopes for removal of soil. This device type is not intended to provide or replace high-level disinfection or sterilization.

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 2 510(k) clearances via K numbers.

    K Number Device Name
    K253267 CORIS System
    DEN240018 CORIS System

    FEI Numbers

    This FDA classification entry is associated with 2 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.