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510(k) Data Aggregation

    K Number
    K252487

    Validate with FDA (Live)

    Device Name
    POWERSEAL Open Extended Jaw Sealer and Divider, Double-Action (PS-0021EJDA)
    Manufacturer
    Gyrus Acmi, Inc.
    Date Cleared
    2026-03-02

    (207 days)

    Product Code
    GEI
    Regulation Number
    878.4400
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Age Range
    All
    Reference & Predicate Devices
    K162047
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The POWERSEAL Open Extended Jaw, Sealer & Divider, Double- Action is a bipolar electrosurgical instrument intended for use in open surgical procedures where ligation and division of vessels, tissue bundles, and lymphatics is desired.

    POWERSEAL Open Extended Jaw, Sealer & Divider, Double-Action instruments can be used on vessels (arteries, veins, pulmonary arteries, pulmonary veins) up to and including 7 mm.

    POWERSEAL Open Extended Jaw, Sealer & Divider, Double-Action instruments are indicated for use in general surgery and such surgical specialties as urologic, colorectal, vascular, thoracic, and gynecologic. Procedures may include, but are not limited to Nissen fundoplication, colectomy, cholecystectomy, adhesiolysis, hysterectomy, and oophorectomy.

    The POWERSEAL Open Extended Jaw has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures. Do not use POWERSEAL Open Extended Jaw for these procedures.

    Device Description

    The POWERSEAL Open Extended Jaw, Sealer & Divider, Double-Action is a bipolar electrosurgical instrument intended for use in open surgical procedures where ligation and division of vessels, tissue bundles, and lymphatics is desired. The jaws of the PSOEJ are designed to work with an electrosurgical unit to seal vessels, and grasp and dissect tissue during open general surgical procedures using radiofrequency (RF) energy, also known as HF energy. A hand-actuated mechanism allows the user to open and close the instrument jaws. The device creates a seal by application of RF energy to vascular structures (vessels, lymphatics) or tissue bundles between the jaws of the device. When the sealing is complete, the user operates a separate control to activate a blade within the device, which divides the tissue along the seal line. The device is supplied sterile and is intended for single use. The POWERSEAL Open Extended Jaw, Sealer and Divider, Double-Action is designed for use with Olympus electrosurgical generators, ESG-400 and ESG-410. The PSOEJ model is specifically for open surgery and is a portfolio expansion to the existing POWERSEAL family (K231327, K212643). The existing and proposed POWERSEAL devices share a similar handle interface designed to enhance usability and improve the surgeon's ergonomic experience.

    AI/ML Overview

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