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510(k) Data Aggregation

    K Number
    K254170

    Validate with FDA (Live)

    Date Cleared
    2026-03-20

    (87 days)

    Product Code
    Regulation Number
    876.5980
    Age Range
    18 - 999
    Reference & Predicate Devices
    Predicate For
    N/A
    Why did this record match?
    Reference Devices :

    K213356

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The PEG Catheter Kit is intended for percutaneous endoscopic gastrostomy placement to provide enteral nutrition and/or medication to patients requiring nutritional support and gastric decompression. This device is indicated for adult use only.

    Device Description

    The Degania Silicone Percutaneous Endoscopic Gastrostomy (PEG) Kit with ENFit® connection is a single-use, sterile, disposable kit intended for the initial percutaneous endoscopic placement of a feeding tube (PEG catheter) into the stomach of adult patients who require enteral nutrition or medication delivery and cannot be fed orally.

    The PEG Kit provides direct access to the stomach through a minimally invasive endoscopic procedure, allowing administration of nutrition, fluids, or medication directly into the gastrointestinal (GI) tract. The system is designed for use in patients with functional GI tracts who are unable to maintain adequate oral intake.

    The device is available in two French sizes (20 Fr and 24 Fr) and four configurations, corresponding to the two standard PEG placement techniques:

    • Push method – 20 Fr
    • Push method – 24 Fr
    • Pull method – 20 Fr
    • Pull method – 24 Fr

    All configurations are supplied sterile (EtO sterilization) and intended for single use.

    Each PEG Kit includes:

    • A silicone feeding catheter (PEG tube) designed for either the Pull or Push placement method
    • A two-way ENFit® connector compliant with ISO 80369-3.
    • An external retention device (ERD) to secure the catheter externally
    • Tools and accessories for site preparation and tube placement (e.g., guidewire, looped placement wire, scalpel, syringe, hypodermic needles, hemostat, drape, and gauze).
    AI/ML Overview

    N/A

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