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

    LAPAROSCOPIC NEEDLE HOLDER

    K Number: K924196 · Decision Jun 25, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    339
    Registration Numbers
    339
    Same Product Code
    6
    Applicant Total
    5
    Review Days
    309

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    LAPAROSCOPIC NEEDLE HOLDER
    K Number
    K924196
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    876.4730
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Nusurg, Inc.
    Date Received
    August 20, 1992
    Decision Date
    June 25, 1993
    Product Code
    FHQ
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    FHQ Holder, Needle, Gastroenterologic

    Similar 510(k) Clearances

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

    WINGED NEEDLE HOLDER

    FDA 510(k)
    FDA Class 1 ·Gastroenterology, Urology

    ENDOSCOPIC NEEDLEHOLDER, MODIFICATION

    FDA 510(k)
    FDA Class 1 ·Gastroenterology, Urology

    MAGNETIC POINT GUARD FOR SURGICAL NEEDLES

    FDA 510(k)
    FDA Class 1 ·Gastroenterology, Urology

    25-100,25-220 VARIOUS NEEDLE HOLDERS

    FDA 510(k)
    FDA Class 1 ·Gastroenterology, Urology

    25-230 TO 25-390 VARIOUS NEEDLE HOLDERS

    FDA 510(k)
    FDA Class 1 ·Gastroenterology, Urology

    NEEDLE HOLDER, MICROVASCULAR

    FDA 510(k)
    FDA Class 1 ·Gastroenterology, Urology
    View all

    Other Clearances by Nusurg, Inc.

    K Number Device Name
    K924792 MULTIPLE PURPOSE FORCEPS
    K930610 TALC DISPENSER SYRINGE
    K924517 AVITENE DISPENSER SYRINGE
    K924372 LAPAROSCOPIC NERVE HOOK