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510(k) Data Aggregation

    K Number
    K984151
    Device Name
    STAINLESS STEEL NONABSORBABLE SURGICAL SUTURE, USP
    Manufacturer
    Date Cleared
    1999-04-28

    (160 days)

    Product Code
    Regulation Number
    878.4495
    Why did this record match?
    Applicant Name (Manufacturer) :

    MILL POND, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Mill Pond, Inc. Stainless Steel Suture used with the Mill Pond, Inc. Suturer has applications in gynecological, orthopedic, and general abdominal and thoracic endoscopic surgical wound closure procedures including creation of anastomoses and hernia repair.
    Device Description
    The subject device is a reuseable hand-held instrument that places stainless steel sutures in an open or minimally invasive surgical procedure. The suture material is supplied in a sterile disposable format that involves structures for dispensing the suture and for mounting this to the instrument. The device consists of a handle, a shaft, and a jaw at the end of the shaft. The jaw, which opens and closes via a manual lever on the handle, holds the tissue to be sutured. An electric switch also on the handle activates a battery-powered motor mechanism that drives the suture wire through the tissue. The jaw is then used to grab both strands of wire near where they emanate from the tissue. A second electric switch on the handle activates another motor that rotates the jaw causing the wire ends to twist about themselves bringing the tissue together until the desired amount of tension is developed. Another manual lever on the handle is used to cut the wire. The device is now ready for the next suture.
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