BEUDAMED
    FDA 510(k) FDA unclassified Substantially Equivalent for Some Indications 🇺🇸 United States

    EPIVIEW

    K Number: K940895 · Decision Nov 22, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    22
    Registration Numbers
    22
    Same Product Code
    79
    Applicant Total
    10
    Review Days
    271

    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
    EPIVIEW
    K Number
    K940895
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent for Some Indications
    Applicant
    Convatec, A Bristol-Myers Squibb Co.
    Date Received
    February 24, 1994
    Decision Date
    November 22, 1994
    Product Code
    MGP
    Advisory Committee
    Unknown
    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
    MGP Dressing, Wound And Burn, Occlusive

    Similar 510(k) Clearances

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

    COLLATEK FOAM

    FDA 510(k)
    FDA Unclassified ·Unknown

    COLLATEK SHEET

    FDA 510(k)
    FDA Unclassified ·Unknown

    LASERSKIN DRESSING

    FDA 510(k)
    FDA Unclassified ·Unknown

    FASTSEAL CHEST WOUND DRESSING

    FDA 510(k)
    FDA Unclassified ·Unknown

    SIMPLICARE TRANSPARENT WOUND DRESSING

    FDA 510(k)
    FDA Unclassified ·Unknown

    DERMAPHYLYX SKIN PROTECTORS, PROTECT IT SKIN PROTECTORS

    FDA 510(k)
    FDA Unclassified ·Unknown
    View all

    Other Clearances by Convatec, A Bristol-Myers Squibb Co.

    K Number Device Name
    K032734 CONVATEC FECAL MANAGEMENT SYSTEM
    K990368 DUODERM HYDROACTIVE GEL WOUND DRESSING
    K982116 AQUACEL HYDROFIBER WOUND DRESSING
    K973806 DUODERM HYDROACTIVE GEL
    K973807 DUODERM HYDROACTIVE PASTE
    K973716 DUODERM EXTRA THIN CGF DRESSING
    K973717 COMBIDERM ACD
    K954918 COMBIDERM ACD
    K942941 CONQUEST MALE CONTINENCE SYSTEM