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

    ULTRACELL NEURO SPONGES

    K Number: K970328 · Decision Apr 21, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    33
    Registration Numbers
    33
    Same Product Code
    23
    Applicant Total
    24
    Review Days
    84

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    Basic Information

    Device Name
    ULTRACELL NEURO SPONGES
    K Number
    K970328
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.4700
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Ultracell Medical Technologies, Inc.
    Date Received
    January 27, 1997
    Decision Date
    April 21, 1997
    Product Code
    HBA
    Advisory Committee
    Neurology
    Review Advisory Committee
    NE
    Third Party
    N

    Classifications

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

    Product Code Device Name
    HBA Neurosurgical Paddie

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    Other Clearances by Ultracell Medical Technologies, Inc.

    K Number Device Name
    K012196 ULTRACELL ABSORBENT STICK
    K972633 ULTRACELL SUCTION SPONGE
    K972634 ULTRACELL SUCTION SPONGE
    K973083 ULTRACELL NEURO SPONGES
    K973558 VISUAL ENDOSCOPIC NON-ALCOHOL ULTRACELL SPONGE (VENUS)
    K973085 ULTRACELL PACKING WITH SLEEVE
    K972635 ULTRACELL SUCTION SPONGE
    K950647 ULTRACELL NEURO SPONGES
    K950370 ULTRACELL ORTHOPEDIC SPONGES
    K950373 ULTRACELL ORTHOPEDIC SPONGES
    Search all 24 clearances from Ultracell Medical Technologies, Inc. →