BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇮🇱 Israel

    ENvizion Medical ENvue; ENvizion Medical Enteral Feeding Tube

    K Number: K182915 · Decision Feb 13, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    228
    Registration Numbers
    229
    Same Product Code
    648
    Applicant Total
    3
    Review Days
    118

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    ENvizion Medical ENvue; ENvizion Medical Enteral Feeding Tube
    K Number
    K182915
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5980
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Envizion Medical , Ltd.
    Date Received
    October 18, 2018
    Decision Date
    February 13, 2019
    Product Code
    KNT
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    KNT Tubes, Gastrointestinal (And Accessories)

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (KNT), ordered by most recent decision date.

    XNY Disposable Gastric Calibration Tube

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Flexi-Seal AIR (with ENFit Connector)

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    hygh-tec Drainage II

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    ZZIREN™ Orogastric Tube; ZZIREN™ SGT Orogastric Tube - 32 Fr (ZZ-SGT-32); ZZIREN™ SGT Orogastric Tube - 36 Fr (ZZ-SGT-36); ZZIREN™ SGT Orogastric Tube - 40 Fr (ZZ-SGT-40); ZZIREN™ GBT Orogastric Tube - 32 Fr (ZZ-GBT-32); ZZIREN™ GBT Orogastric Tube - 36 Fr (ZZ-GBT-36); ZZIREN™ GBT Orogastric Tube - 40 Fr (ZZ-GBT-40)

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Entarik NI Feeding Tube System

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    CORGRIP* SR NG/NI Tube Retention System

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology
    View all

    Other Clearances by Envizion Medical , Ltd.

    K Number Device Name
    K203133 ENvizion Medical ENvue ENvizion Medical Enteral Feeding Tube
    K191387 ENvizion Medical ENVue SYSTEM, ENvizion Medical Enteral Feeding Tube