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510(k) Data Aggregation

    K Number
    K012277
    Device Name
    PORTEX RING PESSARY PVC-NON STERILE; PORTEX RING PESSARY POLYTHENE- NON STERILE
    Manufacturer
    SIMS PORTEX LTD.
    Date Cleared
    2002-02-11

    (207 days)

    Product Code
    HHW
    Regulation Number
    884.3575
    Why did this record match?
    Applicant Name (Manufacturer) :

    SIMS PORTEX LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Portex Ring Pessaries provide vaginal support to prevent the uterus from descending. Designed to ease uterine prolapse. Ring Pessaries are also used to correct other uterine displacements and to alleviate stress incontinence by pressure through the anterior vaginal wall onto the urethra.
    Device Description
    A ring pessary made from PVC or Polythene, available in various sizes, designed to ease uterine prolapse, and provide vaginal support to prevent the uterus from descending.
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    K Number
    K012068
    Device Name
    WALLACE OOCYTE RETRIEVAL SETS 16G, WALLACE OOCYTE RETRIEVAL SET 17G, MODELS MEONS 1633S, MEONS 1733S
    Manufacturer
    SIMS PORTEX LTD.
    Date Cleared
    2001-08-03

    (32 days)

    Product Code
    MQE
    Regulation Number
    884.6100
    Why did this record match?
    Applicant Name (Manufacturer) :

    SIMS PORTEX LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Wallace Oocyte Retrieval Set is intended for ultrasound-guided, transvaginal recovery and collection of oocytes from ovarian follicles. The Wallace Oocyte Retrieval Sets are sterile, single-use intended for ultrasound-guided, transvaginal collection of oocytes for ovarian follicles.
    Device Description
    Wallace Oocyte Retrieval Set is a single-use device provided sterile for ultrasound-guided, transvaginal recovery and collection of oocytes from ovarian follicles. The set consists of a single-lumen, stainless steel needle attached to polyurethane (Tecoflex) tubing 750mm long, using a 25mm long medical grade silicone sleeve. The needle is 33cm in length and available in 16 gauge or 17 gauge, each having echomarking at the distal tip for ultrasound reflection and a plastic hub at the proximal end for ease of guidance by hand. Tubing is attached to the hub of the needle and protrudes a total distance of 700mm until it passes through a silicone bung and terminates in an ABS female luer connector. FEP tubing for suction also protrudes through the bung, and at the other end terminates in a polypropylene luer lock connector.
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    K Number
    K001555
    Device Name
    SURESAMPLE-WALLACE ENDOMETRIAL SAMPLER, ENDO 26
    Manufacturer
    SIMS PORTEX LTD.
    Date Cleared
    2000-08-02

    (76 days)

    Product Code
    HHK
    Regulation Number
    884.1175
    Why did this record match?
    Applicant Name (Manufacturer) :

    SIMS PORTEX LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K000628
    Device Name
    WALLACE OOCYTE RETRIEVAL SET-16G, MODEL MEONS1633; WALLACE OOCYTE RETRIEVAL SET-17G, MODEL MEONS1733
    Manufacturer
    SIMS PORTEX LTD.
    Date Cleared
    2000-03-13

    (18 days)

    Product Code
    MQE
    Regulation Number
    884.6100
    Why did this record match?
    Applicant Name (Manufacturer) :

    SIMS PORTEX LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question

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