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

    NUCLEOTOME TISSUE ASPIRATOR/CUTTER

    K Number: K913145 · Decision Dec 19, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    386
    Registration Numbers
    386
    Same Product Code
    680
    Applicant Total
    12
    Review Days
    156

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    Basic Information

    Device Name
    NUCLEOTOME TISSUE ASPIRATOR/CUTTER
    K Number
    K913145
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.1100
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Surgical Dynamics, Inc.
    Date Received
    July 16, 1991
    Decision Date
    December 19, 1991
    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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    K921950 SURGICAL DYNAMICS DISCOGRAPHY SYSTEM
    K923525 NUCLEOTOME 3.5 MM AUTOMATED PERCUTANEOUS LUMBAR
    K914282 NUCLEOTOME(R) II (VERSION2) TISSUE ASPIRA/CUTTER
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