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

    SISS, INC. (D.B.A.MEDISISS) REPROCESSD ELECTROSURGICAL INSTRUMENTS AND ACCESSORIES

    K Number: K030919 · Decision Jul 3, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    0
    Applicant Total
    6
    Review Days
    101

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    Basic Information

    Device Name
    SISS, INC. (D.B.A.MEDISISS) REPROCESSD ELECTROSURGICAL INSTRUMENTS AND ACCESSORIES
    K Number
    K030919
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.4300
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Medisiss
    Date Received
    March 24, 2003
    Decision Date
    July 3, 2003
    Product Code
    NLR
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    Y

    Classifications

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

    Product Code Device Name
    NLR Unit, Electrosurgical, Endoscopic (With Or Without Accessories), Reprocessed

    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
    K030598 MEDISISS REPROCESSED ULTRASONIC SURGICAL INSTRUMENTS