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

    Sleeved IC

    K Number: K220667 · Decision Dec 8, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    86
    Registration Numbers
    86
    Same Product Code
    81
    Applicant Total
    15
    Review Days
    276

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    Basic Information

    Device Name
    Sleeved IC
    K Number
    K220667
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5130
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Hollister Incorporated
    Date Received
    March 7, 2022
    Decision Date
    December 8, 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 Hollister Incorporated

    K Number Device Name
    K253295 Coude Sleeved IC; Coude Plus Sleeved IC
    K251468 Sleeved IC 3 Family Sleeved IC 3 SWT (name not finalized) Sleeved IC 3 Pocket (name not finalized) Sleeved IC 3 Plus (name not finalized) Sleeved IC 3 Plus Pocket (name not finalized) (N/A)
    K233524 Sleeved IC 2 Family; Sleeved IC 2 SWT (Name not Finalized); Sleeved IC 2 Plus (Name not Finalized); Sleeved IC 2 Pocket (Name not Finalized); Sleeved IC 2 Plus Pocket (Name not Finalized)
    K213575 Female IC (Not Finalized)
    K211436 Intermittent Catheter (Not Finalized)
    K193148 VaPro Plus Pocket, VaPro Plus
    K191633 Infyna Chic
    K183253 ValPro 2 Plus, VaPro 2 Plus Pocket
    K180824 VaPro 2 Intermittent Catheter
    K163179 Onli Intermittent Catheter
    Search all 15 clearances from Hollister Incorporated →