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

    SISS REPROCESSED HOT BIOPSY FORCEPS, LAPAROSCOPIC, ENDOSCOPIC AND ELECTROSURGICAL SURGICAL INSTRUMENTS AND ACCESSORIES

    K Number: K024011 · Decision Dec 19, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    3
    Applicant Total
    8
    Review Days
    15

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    Basic Information

    Device Name
    SISS REPROCESSED HOT BIOPSY FORCEPS, LAPAROSCOPIC, ENDOSCOPIC AND ELECTROSURGICAL SURGICAL INSTRUMENTS AND ACCESSORIES
    K Number
    K024011
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.4300
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Surgical Instruments Service and Savings, Inc.
    Date Received
    December 4, 2002
    Decision Date
    December 19, 2002
    Product Code
    NLU
    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
    NLU Forceps, Biopsy, Electric, Reprocessed

    Similar 510(k) Clearances

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

    REPROCESSED HOT BIOPSY FORCEPS

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    FDA Class 2 ·Gastroenterology, Urology

    VANGUARD REPROCESSED ELECTRIC BIOPSY FORCEPS

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    FDA Class 2 ·Gastroenterology, Urology
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    Other Clearances by Surgical Instruments Service and Savings, Inc.

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    K030179 MEDISISS PHACOEMULSIFICATION TIPS/NEEDLES
    K012644 REPROCESSED TROCARS AND CANNULAS
    K012669 REPROCESSED ELECTROSURGICAL ELECTRODES
    K012667 REPROCESSED ARTHROSCOPIC SHAPERS
    K012658 REPROCESSED COMPRESSION LIMB SLEEVES