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

    Self-Cath Closed System

    K Number: K223821 · Decision Aug 2, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    56
    Registration Numbers
    56
    Same Product Code
    59
    Applicant Total
    15
    Review Days
    224

    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
    Self-Cath Closed System
    K Number
    K223821
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5130
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Coloplast
    Date Received
    December 21, 2022
    Decision Date
    August 2, 2023
    Product Code
    FCM
    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
    FCM Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)

    Similar 510(k) Clearances

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

    BD Touchless™ Plus Unisex Pre-Lubricated Urethral Catheter Kit

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

    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

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

    AMSELF CLOSED CATHETERIZATION SYSTEM

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

    SELF-CATH CS CLOSED URINARY CATHETERIZATION SYSTEM

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

    GUARDIAN CATHETER-INFANT URINARY COLLECTION KIT

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

    AMSURE URETHRAL CATHETERIZATION TRAY

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

    Other Clearances by Coloplast

    K Number Device Name
    K241028 Luja female (20051); Luja female (20052); Luja female (20054); Luja female (20056)
    K231891 Virtue Male Sling System with Alexis Wound Retractor Convenience Kit
    K230165 Luja Coudé (20118 Male CH8 - small packaging (Pocket size)), Luja Coudé (20111 Male CH10 - small packaging (Pocket size)), Luja Coudé (20112 Male CH12 - small packaging (Pocket size)), Luja Coudé (20114 Male CH14 - small packaging (Pocket size)), Luja Coudé (20101 Male CH10 - large packaging), Luja Coudé (20102 Male CH12 - large packaging), Luja Coudé (20104 Male CH14 - large packaging), Luja Coudé (20106 Male CH16 - large packaging)
    K221401 Self-Cath and Self-Cath Plus
    K222059 SpeediCath Flex Set
    K210250 SpeedCath Compact Male
    K203637 SpeediCath Compact (28578, 28580, 28582, 28584), SpeediCath Compact Plus (28810, 28812, 28814)
    K200820 SpeediCath Compact Set
    K192904 SpeediCath Compact Set
    K200142 SpeediCath Soft
    Search all 15 clearances from Coloplast →