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

    DISPOSABLE SCLERAL PLUGS

    K Number: K925671 · Decision Aug 2, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    9
    Applicant Total
    14
    Review Days
    265

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    Basic Information

    Device Name
    DISPOSABLE SCLERAL PLUGS
    K Number
    K925671
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.4155
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    O.R. Specialties, Inc.
    Date Received
    November 10, 1992
    Decision Date
    August 2, 1993
    Product Code
    LXP
    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
    LXP Plug, Scleral

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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
    K923887 JACK'S VENT TUBES
    K923774 DISPOSABLE ENDOILLUMINATOR
    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. →