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510(k) Data Aggregation

    K Number
    K231407
    Device Name
    StarFin
    Manufacturer
    Premium Medical Technology LLC
    Date Cleared
    2023-08-29

    (106 days)

    Product Code
    HIF, GCJ
    Regulation Number
    884.1730
    Why did this record match?
    Applicant Name (Manufacturer) :

    Premium Medical Technology LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The StarFin device is intended for percutaneous insertion into the peritoneal cavity for the purpose of insufflation with carbon dioxide to establish pneumoperioneum for laparoscopic procedures prior to the placement of trocars. The StarFin device is also used for suture capture, externalization and internalization for wound closure after laparoscopic surgery.
    Device Description
    The subject device is a single-use, sterile, laparoscopic needle that is used for percutaneous introduction of a hollow stylet into the abdomen for gas insufflation and establishment of pneumoperitoneum prior to abdominal endoscopy and for closure of trocar site wounds with suture threads. The subject device is equipped with a stainless steel cannular consisting of a beveled needle point for cutting through tissues. Inside the cannula, there is a spring-loaded inner stylet with a rounded blunt tip used for puncture protection. The hollow stainless steel inner stylet provides passing carbon dioxide gas to create pneumoperitoneum. The inner stylet tip is designed for suture capture, passing, externalization, and internalization for wound closure after laparoscopic surgery. The environment of use is professional healthcare.
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