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

    XPS STRAIGHTSHOT MICROBRIDER SYSTEM OR TREBAY SHAVER SYSTEM

    K Number: K973499 · Decision Jan 30, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    386
    Registration Numbers
    386
    Same Product Code
    680
    Applicant Total
    82
    Review Days
    136

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    Basic Information

    Device Name
    XPS STRAIGHTSHOT MICROBRIDER SYSTEM OR TREBAY SHAVER SYSTEM
    K Number
    K973499
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.1100
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Xomed, Inc.
    Date Received
    September 16, 1997
    Decision Date
    January 30, 1998
    Product Code
    HRX
    Advisory Committee
    Orthopedic
    Review Advisory Committee
    OR
    Third Party
    N

    Classifications

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

    Product Code Device Name
    HRX Arthroscope

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    Other Clearances by Xomed, Inc.

    K Number Device Name
    K002395 MODEL 30 CLASSIC PNEUMATONOMETER
    K002987 REDTRONIC XOMED MONOPOLAR ENERGIZED BLADE
    K002828 XPS NITRO SYSTEM
    K002897 TITANIUM MIDDLE EAR PROSTHESES
    K993653 MICRO-FRANCE TROCARS AND ACCESSORIES
    K001148 MEROGEL OTOLOGIC PACK
    K994262 FRONTAL SINUS TREPHINATION CANNULA
    K992855 XPS STRAIGHTSHOT OR MODEL 2000 MICRODEBRIDER SYSTEM OR XPS POWERSCULPT
    K993582 MODIFICATION TO LASER-SHIELD II
    K993655 MICRO-FRANCE ELECTROSURGICAL INSTRUMENTS, VARIOUS
    Search all 82 clearances from Xomed, Inc. →