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

    J105 JAMES SURGICAL SYSTEM I/A PACK

    K Number: K911932 · Decision Aug 26, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    136
    Registration Numbers
    136
    Same Product Code
    12
    Applicant Total
    14
    Review Days
    118

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    Basic Information

    Device Name
    J105 JAMES SURGICAL SYSTEM I/A PACK
    K Number
    K911932
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    882.4525
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    O.R. Specialties, Inc.
    Date Received
    April 30, 1991
    Decision Date
    August 26, 1991
    Product Code
    GZX
    Advisory Committee
    Neurology
    Review Advisory Committee
    NE
    Third Party
    N

    Classifications

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

    Product Code Device Name
    GZX Instrument, Microsurgical

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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
    K923774 DISPOSABLE ENDOILLUMINATOR
    K922355 POLLY'S VITREOUS SCISSORS J-225-S
    K922180 LEWICKY O.R.S. TUBING
    K914038 POLLY'S CUTTER J-225
    K890195 JAMES SURGICAL SYSTEM J1000
    K891161 VITRECTOMY PACK #J120
    Search all 14 clearances from O.R. Specialties, Inc. →