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510(k) Data Aggregation

    K Number
    K222214
    Device Name
    ViVi® Surgical Helmet System (ViVi® Helmet, ViVi® Helmet HPL, ViVi® Hood)
    Manufacturer
    THI Total Healthcare Innovation GmbH
    Date Cleared
    2023-10-17

    (449 days)

    Product Code
    FXY
    Regulation Number
    878.4040
    Why did this record match?
    Product Code :

    FXY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ViVi® Hood is used with the ViVi® Helmet and/or ViVi® Helmet HPL as the ViVi® Surgical Helmet System to provide a barrier between the operating environment and the surgical personnel in order to protect against contamination and/or exposure of infectious body fluids and harmful microorganisms. The ViVi® Helmet and ViVi® Helmet HPL has a battery powered fan, which provides a continuous flow of air in the the ViVi® Hood. The ViVi® Hood is a stand-alone head covers that may be worn with a separate surgical gown. The ViVi® Hood, must be worn over a ViVi® Helmet or ViVi® Helmet HPL.
    Device Description
    The ViVi" Surgical Helmet System is intended to be worn by surgical personnel to provide a barrier between the operating environment and the surgical personnel to help protect against contamination and/or exposure of infectious body fluids and harmful microorganisms. The ViVi" Surgical Helmet System is composed of sterile ViVi" Hood, which is used with the unsterile ViVi" Helmet or the unsterile ViVi" Helmet HPL (High Power LED) with Light Emitting Diode (LED) light to provide a barrier between the operating environment and the surgical personnel to protect against contamination and/or exposure of infectious body fluids and harmful microorganisms. The components include a top-covering sterile surgical hood (ViVi" Hood), an air-exchanging surgical helmet (ViVi" Helmet), and an air-exchanging surgical helmet with LED light (ViVi" Helmet HPL). The surgical hood is sterilized with Ethylene Oxide (EO). The surgical hood is worn over the helmets. The unsterile accessories include a rechargeable Lithium lon battery pack, a battery holster, a 1-bay battery charger, a 4-bay battery charger, and a non-sterile set of three foam pads (ViVi® Muffle).
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    K Number
    K200493
    Device Name
    Stryker T7 Surgical Hoods, Stryker T7 Surgical Togas, Zippered, Stryker T7 Surgical Togas, Zippered with Peel Away Face Shield, Stryker T7 Surgical Togas, Pullover
    Manufacturer
    Stryker Corporation
    Date Cleared
    2020-03-21

    (22 days)

    Product Code
    FXY, FYA
    Regulation Number
    878.4040
    Why did this record match?
    Product Code :

    FXY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Stryker T7 Togas and Stryker T7 Hoods are components of Stryker T7 Personal Protective Equipment (PPE). These surgical devices are intended to protect the patient, health care personnel and operating room personnel against contamination, exposure of infectious bodily fluids, and the transfer of microorganism and particulate material. The Stryker T7 Togas and Stryker T7 Hoods are sterile, single use only devices.
    Device Description
    Stryker T7 Surgical Togas and Stryker T7 Surgical Hoods
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    K Number
    K140588
    Device Name
    FLYTE HYBRID HOOD, FLYTE HYBRID HOOD WITH PEELAWAY LENS
    Manufacturer
    STRYKER CORPORATION
    Date Cleared
    2014-06-26

    (111 days)

    Product Code
    FXY
    Regulation Number
    878.4040
    Why did this record match?
    Product Code :

    FXY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Stryker Flyte Hybrid Hoods are components of a personal protection system and are intended to protect the patient, healthcare personnel, and operating room personel against contamination, exposure of infectious bodily fluids, the transfer of microorganisms and particulate material. The devices are provided sterile and for single use only.
    Device Description
    The Stryker Flyte Hybrid Hoods are intended to be worn over a Flyte Helmet to provide protection to the user's face and head region during surgery. Hoods are worn in conjunction with surgical gowns where the hood material extends beyond the user's upper back and shoulders, while the surgical gown covers the lower portion of the hood up to the user's neck. The Stryker Flyte Hybrid Hood is comprised of 3 main parts: Hood, Filter and Lens. Stryker Flyte Hybrid Hoods are available with either a standard or peel away lens. The devices are prescription devices, provided sterile and single use only.
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