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

    MEDISISS REPROCESSED ULTRASONIC SURGICAL INSTRUMENTS

    K Number: K030598 · Decision Jan 23, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    12
    Registration Numbers
    12
    Same Product Code
    26
    Applicant Total
    6
    Review Days
    332

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    Basic Information

    Device Name
    MEDISISS REPROCESSED ULTRASONIC SURGICAL INSTRUMENTS
    K Number
    K030598
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Medisiss
    Date Received
    February 25, 2003
    Decision Date
    January 23, 2004
    Product Code
    NLQ
    Advisory Committee
    Unknown
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    NLQ Single-Use Reprocessed Ultrasonic Surgical Instruments

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    Other Clearances by Medisiss

    K Number Device Name
    K113028 MEDISISS REPROCESSED ARTHROSCOPIC SHAVERS AND BURS
    K100543 MEDISSISS REPROCESSEDENT ABLATION WANDS (COBLATORS), MODEL#EIC8872-01
    K081559 GENESIS
    K042659 MEDISISS REPROCESSED NON-ELECTRIC GI BIOPSY FORCEPS
    K030919 SISS, INC. (D.B.A.MEDISISS) REPROCESSD ELECTROSURGICAL INSTRUMENTS AND ACCESSORIES