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

    SpeedCath Compact Male

    K Number: K210250 · Decision Apr 26, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    86
    Registration Numbers
    86
    Same Product Code
    81
    Applicant Total
    15
    Review Days
    452

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    Basic Information

    Device Name
    SpeedCath Compact Male
    K Number
    K210250
    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
    January 29, 2021
    Decision Date
    April 26, 2022
    Product Code
    EZD
    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
    EZD Catheter, Straight

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    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)
    K223821 Self-Cath Closed System
    K221401 Self-Cath and Self-Cath Plus
    K222059 SpeediCath Flex Set
    K203637 SpeediCath Compact (28578, 28580, 28582, 28584), SpeediCath Compact Plus (28810, 28812, 28814)
    K200820 SpeediCath Compact Set
    K192904 SpeediCath Compact Set
    K200142 SpeediCath Soft
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