BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    ULTRACELL SUCTION SPONGE

    K Number: K972634 · Decision Dec 17, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    211
    Registration Numbers
    211
    Same Product Code
    110
    Applicant Total
    24
    Review Days
    156

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    Basic Information

    Device Name
    ULTRACELL SUCTION SPONGE
    K Number
    K972634
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4450
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Ultracell Medical Technologies, Inc.
    Date Received
    July 14, 1997
    Decision Date
    December 17, 1997
    Product Code
    GDY
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    GDY Gauze/Sponge, Internal, X-Ray Detectable

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    Other Clearances by Ultracell Medical Technologies, Inc.

    K Number Device Name
    K012196 ULTRACELL ABSORBENT STICK
    K972633 ULTRACELL SUCTION SPONGE
    K973083 ULTRACELL NEURO SPONGES
    K973558 VISUAL ENDOSCOPIC NON-ALCOHOL ULTRACELL SPONGE (VENUS)
    K973085 ULTRACELL PACKING WITH SLEEVE
    K972635 ULTRACELL SUCTION SPONGE
    K970328 ULTRACELL NEURO SPONGES
    K950647 ULTRACELL NEURO SPONGES
    K950370 ULTRACELL ORTHOPEDIC SPONGES
    K950373 ULTRACELL ORTHOPEDIC SPONGES
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