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

    FMS ARTHRO-CUTTER

    K Number: K951701 · Decision May 9, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    85
    Registration Numbers
    85
    Same Product Code
    1
    Applicant Total
    12
    Review Days
    27

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    Basic Information

    Device Name
    FMS ARTHRO-CUTTER
    K Number
    K951701
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    886.4350
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Future Medical Systems, Inc.
    Date Received
    April 12, 1995
    Decision Date
    May 9, 1995
    Product Code
    HNX
    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
    HNX Depressor, Orbital

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    K002040 FMS SOLO
    K980808 ENDO FMS UROLOGY
    K955500 FMS ARTHOPROBE
    K954465 FMS DUO
    K954217 ARTHROPLAST & ARTHRO-CUTTER
    K951843 REF. 4102CV INTERMEDIARY TUBING, REF. 4509CV STERILE ZONE KIT
    K951702 FMS HIGH FLOW ARTHRO-SHEATH
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