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

    DISPOSABLE ENDOILLUMINATOR

    K Number: K923774 · Decision Oct 19, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    96
    Registration Numbers
    96
    Same Product Code
    48
    Applicant Total
    14
    Review Days
    83

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    Basic Information

    Device Name
    DISPOSABLE ENDOILLUMINATOR
    K Number
    K923774
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    874.4350
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    O.R. Specialties, Inc.
    Date Received
    July 28, 1992
    Decision Date
    October 19, 1992
    Product Code
    EQH
    Advisory Committee
    Ear, Nose, Throat
    Review Advisory Committee
    EN
    Third Party
    N

    Classifications

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

    Product Code Device Name
    EQH Source, Carrier, Fiberoptic Light

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    Other Clearances by O.R. Specialties, Inc.

    K Number Device Name
    K942607 LAPAROSCOPIC SCISSORS (DISPOSABLE)
    K923630 PHACO NEEDLES 1000-R & 1000-O NEEDLES
    K925671 DISPOSABLE SCLERAL PLUGS
    K923887 JACK'S VENT TUBES
    K922355 POLLY'S VITREOUS SCISSORS J-225-S
    K922180 LEWICKY O.R.S. TUBING
    K914038 POLLY'S CUTTER J-225
    K911932 J105 JAMES SURGICAL SYSTEM I/A PACK
    K890195 JAMES SURGICAL SYSTEM J1000
    K891161 VITRECTOMY PACK #J120
    Search all 14 clearances from O.R. Specialties, Inc. →