BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    GP GENERAL PURPOSE DRAINAGE CATHETER; MINI-PIGTAIL DRAINAGE CATHETER WITH LOCKING PIGTAIL; GP GENERAL PURPOSE DRAINAGE C

    K Number: K021632 · Decision Jun 13, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    53
    Registration Numbers
    53
    Same Product Code
    10
    Applicant Total
    1
    Review Days
    27

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    Basic Information

    Device Name
    GP GENERAL PURPOSE DRAINAGE CATHETER; MINI-PIGTAIL DRAINAGE CATHETER WITH LOCKING PIGTAIL; GP GENERAL PURPOSE DRAINAGE C
    K Number
    K021632
    Device Class
    FDA class 1
    Clearance Type
    Special
    Regulation Number
    878.4200
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Uresil, L.P.
    Date Received
    May 17, 2002
    Decision Date
    June 13, 2002
    Product Code
    GBO
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    GBO Catheter, Nephrostomy, General & Plastic Surgery

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