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

    TIPI

    K Number: K060526 · Decision Jun 9, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    40
    Registration Numbers
    40
    Same Product Code
    40
    Applicant Total
    2
    Review Days
    102

    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
    TIPI
    K Number
    K060526
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.3575
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Contipi , Ltd.
    Date Received
    February 27, 2006
    Decision Date
    June 9, 2006
    Product Code
    HHW
    Advisory Committee
    Obstetrics/Gynecology
    Review Advisory Committee
    OB
    Third Party
    N

    Classifications

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

    Product Code Device Name
    HHW Pessary, Vaginal

    Similar 510(k) Clearances

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

    Milex™ Incontinence Dish Pessaries; Milex™ Incontinence Dish Pessaries with Support; Milex™ Cube Pessaries; Milex™ Cube Pessaries with Drainage Holes

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    CooperSurgical Milex® Pessaries

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    Cntrl+ Bladder Support Pessary

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    Reia pessary

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    Yoni.Fit Bladder Support

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    Uresta®

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology
    View all

    Other Clearances by Contipi , Ltd.

    K Number Device Name
    K131198 TIPI OTC