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

    ULTRACELL ABSORBENT STICK

    K Number: K012196 · Decision Aug 24, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    78
    Registration Numbers
    79
    Same Product Code
    46
    Applicant Total
    24
    Review Days
    42

    Basic Information

    Device Name
    ULTRACELL ABSORBENT STICK
    K Number
    K012196
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.4790
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    ULTRACELL MEDICAL TECHNOLOGIES, INC.
    Date Received
    July 13, 2001
    Decision Date
    August 24, 2001
    Product Code
    HOZ
    Advisory Committee
    Ophthalmic
    Review Advisory Committee
    OP
    Third Party
    N

    Classifications

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

    Product Code Device Name
    HOZ Sponge, Ophthalmic

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    Other Clearances by ULTRACELL MEDICAL TECHNOLOGIES, INC.

    K Number Device Name
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    K973558 VISUAL ENDOSCOPIC NON-ALCOHOL ULTRACELL SPONGE (VENUS)
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    K972635 ULTRACELL SUCTION SPONGE
    K970328 ULTRACELL NEURO SPONGES
    K950647 ULTRACELL NEURO SPONGES
    K950373 ULTRACELL ORTHOPEDIC SPONGES
    K950370 ULTRACELL ORTHOPEDIC SPONGES
    Search all 24 clearances from ULTRACELL MEDICAL TECHNOLOGIES, INC. →