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

    Flexi-Seal PROTECT PLUS Fecal Management System (with ENFit Connector)

    K Number: K190114 · Decision Apr 30, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    228
    Registration Numbers
    229
    Same Product Code
    648
    Applicant Total
    10
    Review Days
    96

    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
    Flexi-Seal PROTECT PLUS Fecal Management System (with ENFit Connector)
    K Number
    K190114
    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 Limited
    Date Received
    January 24, 2019
    Decision Date
    April 30, 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 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
    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
    K161344 GentleCath Glide Intermittent Catheter
    K152926 AQUACEL Ag Surgical SP Dressing