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

    CATARACT TRAY

    K Number: K842647 · Decision May 9, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    206
    Registration Numbers
    207
    Same Product Code
    53
    Applicant Total
    91
    Review Days
    303

    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
    CATARACT TRAY
    K Number
    K842647
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    886.4350
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Applicant
    Deroyal Industries, Inc.
    Date Received
    July 10, 1984
    Decision Date
    May 9, 1985
    Product Code
    HNN
    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
    HNN Knife, Ophthalmic

    Similar 510(k) Clearances

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

    CLEARCUT S SAFETY KNIFE

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    OPHTHALMIC KNIFE

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    RETRACTIVE INCISION MICROMETER (RIM) GUAGE

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    MVR/STILETTO BLADE 20GA. - P/N 1900

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    PRISMA DISPOSABLE MVR/STILETTO BLADE

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    OPHTHALMIC TIP & BLADE SCALPELS

    FDA 510(k)
    FDA Class 1 ·Ophthalmic
    View all

    Other Clearances by Deroyal Industries, Inc.

    K Number Device Name
    K250586 Prospera Spectruum Negative Pressure Wound Therapy Black Foam Kits and White Foam Accessory
    K230233 Prospera Spectruum Negative Pressure Wound Therapy System
    K200631 DeRoyal Temperature Monitoring Probe
    K200757 Foley Catheter with Temperature Sensor
    K200319 HYDRO-TEMP Neonatal Skin Surface Temperature Sensor, HYDRO-TEMP Neonatal Skin Surface Temperature Sensor with Interface Cable
    K193027 Esophageal Stethoscope 9 French, Esophageal Stethoscope 12 French, Esophageal Stethoscope 18 French, Esophageal Stethoscope, 24 French
    K191425 Hydro-Temp Neonatal Skin Temperature Probe Cover
    K173072 Algidex Ag Silver Alginate Wound Dressing
    K171475 DeRoyal Laprador Specimen Retrieval System
    K152978 DeRoyal Angiography Kits
    Search all 91 clearances from Deroyal Industries, Inc. →