BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    Avanos* CORTRAK* 2 Enteral Access System (EAS)

    K Number: K220588 · Decision Apr 22, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    228
    Registration Numbers
    229
    Same Product Code
    648
    Applicant Total
    8
    Review Days
    52

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    Basic Information

    Device Name
    Avanos* CORTRAK* 2 Enteral Access System (EAS)
    K Number
    K220588
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5980
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Avanos Medical, Inc.
    Date Received
    March 1, 2022
    Decision Date
    April 22, 2022
    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)

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    Other Clearances by Avanos Medical, Inc.

    K Number Device Name
    K243572 Game Ready system (550500-04); Game Ready Control Unit (550550-04); Game Ready Full Leg Boot Wrap - Medium (590923-04); Game Ready Full Leg Boot Wrap - Large (590922-04); Game Ready C-T Spine Wrap (590502-04); Game Ready Half Leg Boot (590906-04); Game Ready Back Wrap (590500-04); Game Ready Hand/Wrist Wrap (590811-04); Game Ready Flexed Elbow Wrap (590903-04); Game Ready Straight Elbow Wrap (590200-04); Game Ready Shoulder Wrap, Medium, Right (590422-04); Game Ready Shoulder Wrap, La
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    K242057 COOLIEF* Radiofrequency Generator (CRG-BASIC, CRG-BASIC-R, CRG-ADVANCED, CRG-ADVANCED-R)
    K240965 CORTRAK* 2 Enteral Access System (20-0950)
    K203066 COOLIEF Cooled Radiofrequency Kit Advanced
    K192491 Coolief Radiofrequency Generator (CRG) System
    K191340 CORTRAK* 2 Equilateral Enteral Access System