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

    D.O.R.C. HEXON ILLUMINATION SYSTEM

    K Number: K973229 · Decision Nov 25, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    28
    Registration Numbers
    28
    Same Product Code
    39
    Applicant Total
    10
    Review Days
    90

    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
    D.O.R.C. HEXON ILLUMINATION SYSTEM
    K Number
    K973229
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Dutch Ophthalmic USA, Inc.
    Date Received
    August 27, 1997
    Decision Date
    November 25, 1997
    Product Code
    MPA
    Advisory Committee
    Gastroenterology, Urology
    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
    MPA Endoilluminator

    Similar 510(k) Clearances

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

    Alcon 27GA Chandelier (8065000252); Alcon 27+ DS Wide Angle Endoilluminator (8065000253); Alcon 27+ DS Endoilluminator (8065000256);

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Midfield Light Pipe, 23ga (3269.M06-00); Midfield Light Pipe, 25ga (3269.M05-00); Midfield Light Pipe, 27ga (3269.M04-00)

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    ITrack Advance Canaloplasty Microcatheter with Advanced Delivery System

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Nam illumination probe with chopper

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    23ga Chandelier Illuminator, 25ga Chandelier Illuminator

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Synergetics PHOTON EX

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology
    View all

    Other Clearances by Dutch Ophthalmic USA, Inc.

    K Number Device Name
    K012821 D.O.R.C. CRYOSTAR CRYOSURGICAL SYSTEM
    K010082 D.O.R.C. HARMONY TOTAL TTC VITRECTOMY SYSTEM
    K983797 D.O.R.C. HARMONY TOTAL VITRECTOMY SYSTEM
    K980636 FIBER OPTIC ENDOILLUMINATION PROBE
    K973757 D.O.R.C. SOLUX LIGHT SOURCE
    K962135 D.O.R.C. MICRODIATHERMY SYSTEM
    K954842 D.O.R.C. VFI/VFE SYSTEM
    K940373 OPHTHALMIC CRYO UNIT
    K902491 ECKHARDT TEMPORARY KERATOPROSTHESIS