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510(k) Data Aggregation

    K Number
    K230621
    Device Name
    LaproGlide™ Disposable Monopolar PTFE Coated Laparoscopic Probes
    Date Cleared
    2023-12-01

    (270 days)

    Product Code
    Regulation Number
    878.4400
    Why did this record match?
    Applicant Name (Manufacturer) :

    Surgical Principals, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The LaproGlide™ Disposable Monopolar PTFE Coated Laparoscopic Probes are intended to be used in general laparoscopic surgical procedures requiring the use of Monpolar electrosurgical cutting and/or coagulation.
    Device Description
    The LaproGlide™ Disposable Monopolar PTFE Coated Laparoscopic Probes are sterile packaged single use stainless-steel electrodes coated with a non-stick material (PTFE), which is used to cut and coagulate soft tissue. The PTFE Coating reduced the buildup of eschar on the electrode during use; thus, eliminates the need to clean or "scrape" the electrode on an abrasive surface to remove the eschar buildup. These devices have a 5mm diameter with working lengths up to 44cm and includes various tip geometries (L-hook, Spatula, etc.). Additionally, devices are provided in either foot-activated (via a standard 4mm female monopolar connector) or hand-activated (via a standard electrosurgical pencil) versions.
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