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510(k) Data Aggregation

    K Number
    K250481
    Device Name
    Extension Feeding Set with ENFit™ Connectors
    Manufacturer
    Sky Medical, a.s.
    Date Cleared
    2025-04-18

    (58 days)

    Product Code
    PIF
    Regulation Number
    876.5980
    Why did this record match?
    Applicant Name (Manufacturer) :

    Sky Medical, a.s.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Extension Feeding Set with ENFit™ connectors is intended for use as an extension set for a Low-Profile Gastrostomy Replacement Tube (G. Button). It is intended to provide delivery of Enteral Nutrition from administration media with ENFit™ connector and or medication into a single patient, for a maximum of two weeks. Feeding via an Extension Feeding Set is advocated when nutrition cannot be provided to the patient by mouth and therefore cannot consume an adequate number of calories because of an underlying condition.
    Device Description
    The Extension Feeding Set with ENFit™ connectors (Extension Feeding Set), comprises a hollow tube with two different connectors at each end: an ENFit™ connector connecting to an administration media, the other is a secure lock connector for connecting to a gastric feeding device. The Extension Feeding Set is sterile, single patient use device, consisting of a polyvinylchloride tube, ABS secure lock connector, Tritan ENFit™ connector. The connectors on the proximal end of the extension sets are ENFit™ ISO 80369-3 compliant. The ENFit™ connector allows for connections of enteral specific applications while reducing the likelihood of misconnections to non-enteral devices. Extension Feeding Sets are available in three lengths: 5 cm (2"), 30.5 cm (12") or 61 cm (24"). All Extension Feeding Sets are available with either a right-angle secure lock connector or a straight secure lock connector. Both connectors are compatible with G. Button.
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