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

    GentleCath Glide Intermittent Catheter

    K Number: K161344 · Decision Sep 20, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    114
    Registration Numbers
    114
    Same Product Code
    237
    Applicant Total
    10
    Review Days
    130

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    Basic Information

    Device Name
    GentleCath Glide Intermittent Catheter
    K Number
    K161344
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5130
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Convatec Limited
    Date Received
    May 13, 2016
    Decision Date
    September 20, 2016
    Product Code
    KOD
    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
    KOD Catheter, Urological

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    Other Clearances by Convatec Limited

    K Number Device Name
    K252943 GentleCath Air for Men; GentleCath Glide Intermittent Catheter; GentleCath Air for Women
    K250891 Cure Catheter Insertion Kit (K1); Cure Catheter Insertion Kit (K2); Cure Catheter Insertion Kit (K2-90); Cure Catheter Insertion Kit (K3); Cure Hydrophilic Catheter Kit (HM12UK); Cure Hydrophilic Catheter Kit (HM14UK); Cure Hydrophilic Catheter Kit (HM16UK); Cure Pocket Catheter Kit (M14UK); Cure Catheter Closed System Kit (CS8); Cure Catheter Closed System Kit (CS10); Cure Catheter Closed System Kit (CS12); Cure Catheter Closed System Kit (CS14); Cure Catheter Closed System Kit (CS14C
    K213283 GentleCath Air for Men Hydrophilic Intermittent Urinary Catheter
    K190114 Flexi-Seal PROTECT PLUS Fecal Management System (with ENFit Connector)
    K180205 AVELLE Negative Pressure Wound Therapy System
    K181206 GentleCath Glide Intermittent Urinary Catheter
    K173675 AQUACEL Ag+ EXTRA Enhanced Hydrofiber Dressing with Silver and Strengthening Fiber
    K172924 GentleCath Intermittent Urinary Catheter
    K152926 AQUACEL Ag Surgical SP Dressing