BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇬🇧 United Kingdom

    Flexi-Seal AIR (with ENFit Connector)

    K Number: K243228 · Decision Mar 28, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    242
    Registration Numbers
    243
    Same Product Code
    648
    Applicant Total
    2
    Review Days
    171

    Basic Information

    Device Name
    Flexi-Seal AIR (with ENFit Connector)
    K Number
    K243228
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5980
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Convatec
    Date Received
    October 8, 2024
    Decision Date
    March 28, 2025
    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 Convatec

    K Number Device Name
    K250699 Cure Twist Female 8 Catheter (T8); Cure Twist Female 10 Catheter (T10); Cure Twist Female 12 Catheter (T12); Cure Twist Female 14 Catheter (T14); Cure Twist Female 16 Catheter (T16); Cure Twist Female 8 Catheter Kit with supplies (T8K); Cure Twist Female 10 Catheter Kit with supplies (T10K); Cure Twist Female 12 Catheter Kit with supplies (T12K); Cure Twist Female 14 Catheter Kit with supplies (T14K); Cure Twist Female 16 Catheter Kit with supplies (T16K)