BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇬🇧 United Kingdom

    PORTEX RING PESSARY PVC-NON STERILE; PORTEX RING PESSARY POLYTHENE- NON STERILE

    K Number: K012277 · Decision Feb 11, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    40
    Registration Numbers
    40
    Same Product Code
    40
    Applicant Total
    4
    Review Days
    207

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    Basic Information

    Device Name
    PORTEX RING PESSARY PVC-NON STERILE; PORTEX RING PESSARY POLYTHENE- NON STERILE
    K Number
    K012277
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.3575
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Sims Portex , Ltd.
    Date Received
    July 19, 2001
    Decision Date
    February 11, 2002
    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

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    Other Clearances by Sims Portex , Ltd.

    K Number Device Name
    K012068 WALLACE OOCYTE RETRIEVAL SETS 16G, WALLACE OOCYTE RETRIEVAL SET 17G, MODELS MEONS 1633S, MEONS 1733S
    K001555 SURESAMPLE-WALLACE ENDOMETRIAL SAMPLER, ENDO 26
    K000628 WALLACE OOCYTE RETRIEVAL SET-16G, MODEL MEONS1633; WALLACE OOCYTE RETRIEVAL SET-17G, MODEL MEONS1733