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

    VISUAL ENDOSCOPIC NON-ALCOHOL ULTRACELL SPONGE (VENUS)

    K Number: K973558 · Decision Nov 24, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    24
    Registration Numbers
    24
    Same Product Code
    56
    Applicant Total
    24
    Review Days
    66

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    Basic Information

    Device Name
    VISUAL ENDOSCOPIC NON-ALCOHOL ULTRACELL SPONGE (VENUS)
    K Number
    K973558
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Ultracell Medical Technologies, Inc.
    Date Received
    September 19, 1997
    Decision Date
    November 24, 1997
    Product Code
    FEB
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

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

    Product Code Device Name
    FEB Accessories, Cleaning, For Endoscope

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    Other Clearances by Ultracell Medical Technologies, Inc.

    K Number Device Name
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    K972635 ULTRACELL SUCTION SPONGE
    K970328 ULTRACELL NEURO SPONGES
    K950647 ULTRACELL NEURO SPONGES
    K950370 ULTRACELL ORTHOPEDIC SPONGES
    K950373 ULTRACELL ORTHOPEDIC SPONGES
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