BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    XODUS MEDICAL ANTI-FOG SOLUTION

    K Number: K063587 · Decision Jan 9, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    64
    Registration Numbers
    64
    Same Product Code
    26
    Applicant Total
    6
    Review Days
    39

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    XODUS MEDICAL ANTI-FOG SOLUTION
    K Number
    K063587
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Xodus Medical, Inc.
    Date Received
    December 1, 2006
    Decision Date
    January 9, 2007
    Product Code
    OCT
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    OCT Anti Fog Solution And Accessories, Endoscopy

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (OCT), ordered by most recent decision date.

    KnoxFog Anti-fogging Device

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    GOLFF Sterile Anti-Fog Solution

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    E-Brik Visualization Assistant

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Konix Anti-Fog Solution

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    AMD Anti-Fog Solution

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    VitreOx Anti-fog Solution

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology
    View all

    Other Clearances by Xodus Medical, Inc.

    K Number Device Name
    K260903 Hot Pink Pad Warming System
    K182080 Scope Antifogging System
    K081647 ELECTROSURGICAL PENCIL WITH PTFE COATED & UNCOATED ELECTRODE TIPS
    K053433 CAUTERY TIP CLEANER, MODEL 30500
    K053321 LIGHT GUARD LIGHT HANDLE AND LIGHT HANDLE COVER