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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
    K011907
    Device Name
    SNUGGLE WARM 4000 CONVECTIVE WARMING SYSTEM
    Manufacturer
    SIMS LEVEL 1, INC.
    Date Cleared
    2001-12-18

    (183 days)

    Product Code
    DWJ
    Regulation Number
    870.5900
    Why did this record match?
    Applicant Name (Manufacturer) :

    SIMS LEVEL 1, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Snuggle Warm 4000 Convective Warming System is intended for thermal regulating a patient's temperature to prevent hypothermia by a warm air heated blanket system to reduce cold discomfort during and after surgical procedures. It is intended for use by appropriately trained healthcare professionals in clinical environments.
    Device Description
    The Snuggle Warm consists of a disposable single use warming blanket that is placed in contact with the patient and a warming unit with a hose end temperature control connected to the blanket. The warming unit generates warm air that is distributed throughout the warming blanket to warm the patient during and after surgical procedures. It is intended for use by appropriately trained healthcare professionals in clinical environments.
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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
    K011925
    Device Name
    HYPODERMIC NEEDLE-PRO NEEDLE WITH NEEDLE PROTECTION DEVICE; HYPODERMIC NEEDLE-PRO SYRINGE & NEEDLE WITH NEEDLE PROTECTIO
    Manufacturer
    SIMS PORTEX, INC.
    Date Cleared
    2001-07-12

    (22 days)

    Product Code
    FMI
    Regulation Number
    880.5570
    Why did this record match?
    Applicant Name (Manufacturer) :

    SIMS PORTEX, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This device is intended for injection or aspiration of fluids utilizing a luer slip syringe. The needle protection device covers the needle after use to help prevent needle sticks. The Needle-Pro® device is not designed for use with a luer lock syringe.
    Device Description
    This device is intended for injection or aspiration of fluids utilizing a luer slip syringe. The needle protection device is an integral component of the device as it comes pre-attached to the needle. Once the needle/needle protection device is attached to a syringe, the collar hoop hinders removal of the needle protection device from the needle. The Needle-Pro® sheath may be adjusted relative to the needle bevel by swiveling the orange arm to the desired position. After the procedure is completed, the needle is pressed into the sheath using a onehanded technique. As the needle enters the protective sheath, the needle protection device engages and the needle is contained within the sheath. The device should be immediately be disposed into a sharps container. This device is not designed for use with a luer lock syringe. The device is supplied with 25G, 26G, 27G needles both with and without a syringe.
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    K Number
    K010426
    Device Name
    PROPORT PLASTIC VENOUS IMPLANTABLE ACCESS SYSTEMS PRE-ASSEMBLED WITH SILICONE CATHETER
    Manufacturer
    SIMS DELTEC, INC.
    Date Cleared
    2001-03-08

    (23 days)

    Product Code
    LJT
    Regulation Number
    880.5965
    Why did this record match?
    Applicant Name (Manufacturer) :

    SIMS DELTEC, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K002201
    Device Name
    ELECTROSTATIC HYDROPHOBIC BREATHING FILTER
    Manufacturer
    SIMS PORTEX, INC.
    Date Cleared
    2001-02-05

    (200 days)

    Product Code
    CAH
    Regulation Number
    868.5260
    Why did this record match?
    Applicant Name (Manufacturer) :

    SIMS PORTEX, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K002506
    Device Name
    BREATHING FILTER FOR DISPOSABLE ANESTHESIA BREATHING CIRCUIT
    Manufacturer
    SIMS PORTEX, INC.
    Date Cleared
    2000-12-14

    (121 days)

    Product Code
    CAH
    Regulation Number
    868.5260
    Why did this record match?
    Applicant Name (Manufacturer) :

    SIMS PORTEX, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K001764
    Device Name
    HOTLINE 2 FLUID WARMER
    Manufacturer
    SIMS LEVEL 1, INC.
    Date Cleared
    2000-08-09

    (58 days)

    Product Code
    LGZ
    Regulation Number
    880.5725
    Why did this record match?
    Applicant Name (Manufacturer) :

    SIMS LEVEL 1, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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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
    K001318
    Device Name
    CPAP SYSTEM, MODEL 102001
    Manufacturer
    SIMS PORTEX, INC.
    Date Cleared
    2000-07-20

    (85 days)

    Product Code
    BYE
    Regulation Number
    868.5965
    Why did this record match?
    Applicant Name (Manufacturer) :

    SIMS PORTEX, INC

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