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

    ASCON OPHTHALMIC SPONGE

    K Number: K852055 · Decision Sep 4, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    77
    Registration Numbers
    78
    Same Product Code
    46
    Applicant Total
    6
    Review Days
    118

    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
    ASCON OPHTHALMIC SPONGE
    K Number
    K852055
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.4790
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Applicant
    Ascon Medical Instruments, Ltd.
    Date Received
    May 9, 1985
    Decision Date
    September 4, 1985
    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

    Similar 510(k) Clearances

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

    SUNTOUCH EYE SPEAR

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    NETWORK EYE SPEARS, POINTS, DRAINS, WICKS AND SHIELDS

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    ALPHAMED SURGICAL SPEAR, MODEL 70-5000

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    CENEFOM PVA SURGICAL SPEAR

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    ULTRACELL ABSORBENT STICK

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    MEROCEL CORNELL LID AND LASH GUARD, MEROCEL AND KEROCEL OPHTHALMIC SPONGES

    FDA 510(k)
    FDA Class 2 ·Ophthalmic
    View all

    Other Clearances by Ascon Medical Instruments, Ltd.

    K Number Device Name
    K852054 CONTACT LENS LOUPE, INSPETION LOUPE
    K852548 ATL 225 MW TRAIL LENS SET
    K852057 ASCON SURGICAL INSTRUMENTS
    K852056 ACC CROSS CYLINDERS
    K852126 ATF 101 TRAIL FRAME