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

    MEDISISS PHACOEMULSIFICATION TIPS/NEEDLES

    K Number: K030179 · Decision Jan 24, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    4
    Applicant Total
    8
    Review Days
    7

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    Basic Information

    Device Name
    MEDISISS PHACOEMULSIFICATION TIPS/NEEDLES
    K Number
    K030179
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    886.4670
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Surgical Instruments Service and Savings, Inc.
    Date Received
    January 17, 2003
    Decision Date
    January 24, 2003
    Product Code
    NKX
    Advisory Committee
    Ophthalmic
    Review Advisory Committee
    OP
    Third Party
    Y

    Classifications

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

    Product Code Device Name
    NKX Needle, Phacoemulsification, Reprocessed

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (NKX), ordered by most recent decision date.

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    VANGUARD REPROCESSED PHACOEMULSIFICATION

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    Other Clearances by Surgical Instruments Service and Savings, Inc.

    K Number Device Name
    K124033 MEDISISS REPROCESSED ULTRASONIC INSTRUMENTS
    K031869 SISS INC. (D.B.A. MEDISISS) REPROCESSED ELECTROSURGICAL INSTRUMENTS AND ACCESSORIES
    K024011 SISS REPROCESSED HOT BIOPSY FORCEPS, LAPAROSCOPIC, ENDOSCOPIC AND ELECTROSURGICAL SURGICAL INSTRUMENTS AND ACCESSORIES
    K012644 REPROCESSED TROCARS AND CANNULAS
    K012669 REPROCESSED ELECTROSURGICAL ELECTRODES
    K012667 REPROCESSED ARTHROSCOPIC SHAPERS
    K012658 REPROCESSED COMPRESSION LIMB SLEEVES