Search Filters

Search Results

Found 9 results

510(k) Data Aggregation

    K Number
    K173431
    Device Name
    Towako Transmyometrial Embryo Transfer Set
    Manufacturer
    William A. Cook Australia PTY LTD
    Date Cleared
    2018-05-18

    (197 days)

    Product Code
    MQF, MOF
    Regulation Number
    884.6110
    Why did this record match?
    Applicant Name (Manufacturer) :

    William A. Cook Australia PTY LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Towako Transmyometrial Embryo Transfer Set is indicated for transfering IVF embryo(s) into the endometrial cavity through the myometrium for patients undergoing Assisted Reproductive Procedures.
    Device Description
    The Towako Transmyometrial Embryo Transfer Set is comprised of an echo tipped stainless steel 19 Gauge needle, matching stainless steel stylet and a 2 Fr polyethylene transfer catheter. The stylet fits into the needle with both bevels flush, and is inserted with the stylet in-situ to prevent blockage of the needle lumen and provide stiffness to the needle during insertion. When the needle is positioned correctly, the stylet is removed and the transfer catheter with the embryos loaded is inserted to allow embryo transfer. The device is used when difficulty is experienced in transferring embryos into the uterine cavity using a standard trans-cervical route. The Towako Transmyometrial Embryo Transfer Set is a sterile and single-use device.
    Ask a Question
    K Number
    K171611
    Device Name
    Double Lumen Ovum Aspiration Needles
    Manufacturer
    William A. Cook Australia Pty Ltd
    Date Cleared
    2017-12-15

    (197 days)

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

    William A. Cook Australia Pty Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Double Lumen Ovum Aspiration Need for laparoscopic or ultrasound guided transvaginal aspiration and flushing of oocytes from ovarian follicles for patients undergoing Assisted Reproductive procedures.
    Device Description
    Double Lumen Ovum Pick-up Needles consist of a double lumen stainless steel needle with a manipulating handle. The manipulating handle has two ports: the central port through which oocytes are aspirated via the central lumen, and a secondary side port to allow flushing of follicles via a secondary lumen. The needle is intended to be used to aspirate oocytes from follicles of human ovaries via a laparoscopic or ultrasound guided transvaginal path. The Double Lumen Ovum Aspiration Needles are sterile and single-use devices. The Double Lumen Ovum Aspiration Needles are available in 16 or 17 gauge sizes and three lengths: 30, 33 and 35 cm. The needles are provided with an aspiration tube of 75 cm length and a vacuum tube with a length of 70 or 100 cm.
    Ask a Question
    K Number
    K160753
    Device Name
    COOK Vacuum Pump
    Manufacturer
    WILLIAM A. COOK AUSTRALIA PTY LTD
    Date Cleared
    2017-06-13

    (452 days)

    Product Code
    MQG, MOG
    Regulation Number
    884.6120
    Why did this record match?
    Applicant Name (Manufacturer) :

    WILLIAM A. COOK AUSTRALIA PTY LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The COOK Vacuum Pump is intended for the aspiration of eggs (ova), during assisted reproduction procedures using low flow, intermittent vacuum.
    Device Description
    The COOK Vacuum Pump (K-MAR-5200) is an electrically-powered, vacuum pump that is used for the collection of ova (eggs) from ovarian follicles for use in in vitro fertilization (IVF) procedures. The COOK Vacuum Pump provides vacuum levels ranging from -10 mmHg to -500 mmHg. . It is supplied non-sterile. The disposable Vacuum Line with Hydrophobic Filter (K-DVLF-240) is an accessory to the COOK Vacuum Pump and is used to connect the vacuum pump to an ovum aspiration needle. This component has been designed and tested to withstand the maximum vacuum pressures associated with the COOK Vacuum Pump. The Vacuum Line with Hydrophobic Filter (K-DVLF-240) is provided sterile (ethylene oxide sterilization) for single use only, and has a shelf-life of three years.
    Ask a Question
    K Number
    K170257
    Device Name
    Sydney IVF Culture Oil
    Manufacturer
    William A. Cook Australia Pty Ltd
    Date Cleared
    2017-02-24

    (28 days)

    Product Code
    MQL
    Regulation Number
    884.6180
    Why did this record match?
    Applicant Name (Manufacturer) :

    William A. Cook Australia Pty Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Sydney IVF Culture Oil is intended for use as an oil overlay for culture of gametes, zygotes, or embryos in assisted reproduction technology (ART) and micro-manipulation procedures.
    Device Description
    Sydney IVF Culture Oil is designed to protect gametes and embryos during ART processing by providing a barrier between the embryo culture media and the air, thereby minimizing evaporation, and reducing fluctuations in osmolality. Sydney IVF Culture Oil consists of pharmaceutical grade mineral oil. Sydney IVF Culture Oil is provided in glass vials (50 ml). This product is a single use, aseptically-filtered device.
    Ask a Question
    K Number
    K153478
    Device Name
    Sydney IVF Gamete Buffer
    Manufacturer
    WILLIAM A. COOK AUSTRALIA PTY LTD
    Date Cleared
    2016-08-15

    (257 days)

    Product Code
    MQL, MOL
    Regulation Number
    884.6180
    Why did this record match?
    Applicant Name (Manufacturer) :

    WILLIAM A. COOK AUSTRALIA PTY LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Sydney IVF Gamete Buffer is used to physically wash and store gametes in preparation for the IVF process.
    Device Description
    Sydney IVF Gamete Buffer is a HEPES buffered physiologic solution used to physically wash gametes in preparation for the fertilization step in the IVF process. Sydney IVF Gamete Buffer can be used for both sperm and oocytes. This solution can be used to wash oocytes of excess blood following aspiration and also as a short term storage solution until transfer to a fertilisation medium. Sydney IVF Gamete Buffer is based upon the formulation of a 20 mM HEPES buffered media containing salts, non-essential amino acids, glucose, 10 mg/mL Human Serum Albumin (HSA) and 0.01 mg/mL Gentamicin. Sydney IVF Gamete Buffer is packaged in 20, 50 or 100 mL borosilicate Type I glass vials with Fluorotec coated rubber stoppers held in place with a tamper evident seal. These products are single use, sterile (aseptic filtration) devices. It has a shelf life of 20 weeks when stored at 2 - 8 °C.
    Ask a Question
    K Number
    K160814
    Device Name
    Sydney IVF Sperm Cryopreservation Buffer
    Manufacturer
    WILLIAM A. COOK AUSTRALIA PTY LTD
    Date Cleared
    2016-04-22

    (29 days)

    Product Code
    MQL, MOL
    Regulation Number
    884.6180
    Why did this record match?
    Applicant Name (Manufacturer) :

    WILLIAM A. COOK AUSTRALIA PTY LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Sydney IVF Sperm Cryopreservation Buffer is intended for use as a buffer to prevent damage to sperm samples during cryopreservation and thawing.
    Device Description
    Sydney IVF Sperm Cryopreservation Buffer consists of an aqueous solution intended for use as a buffer to prevent damage to sperm samples during cryopreservation and thawing. The IVF technician will use the buffer to cryopreserve washed spermatozoa, including MESA (microsurgical epididymal sperm aspiration) and TESA (testicular sperm extraction) samples. Sydney IVF Sperm Cryopreservation Buffer contains glycerol as a cryoprotectant, and HEPES (4-(2-hydroxyethyl)-1-piperazineethanesulfonic acid) as a buffer. This product is used to cryopreserve washed sperm and store them for future use. Sydney IVF Sperm Cryopreservation Buffer contains Human Serum Albumin (HSA) (4 mg/mL) and Gentamicin (0.01 mg/mL). The device is available as a 20 mL fill only. The Sydney IVF Sperm Cryopreservation Buffer is provided in glass vials with Fluorotec coated rubber stoppers held in place with a tamper evident seal. These products are single use, sterile (aseptic filtration) devices.
    Ask a Question
    K Number
    K151367
    Device Name
    Sydney IVF Hyaluronidase
    Manufacturer
    WILLIAM A. COOK AUSTRALIA PTY LTD
    Date Cleared
    2016-01-27

    (251 days)

    Product Code
    MQL, MOL
    Regulation Number
    884.6180
    Why did this record match?
    Applicant Name (Manufacturer) :

    WILLIAM A. COOK AUSTRALIA PTY LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Sydney IVF Hyaluronidase is intended for use to facilitate removal of the cumulus cells surrounding oocytes in assisted reproduction technology (ART) procedures.
    Device Description
    Sydney IVF Hyaluronidase is an enzymatic preparation containing 80 IU/mL Hyaluronidase (of ovine origin) in a Bicarbonate buffered media supplemented with 5 mg/mL Human Serum Albumin (HSA) and 10 ug/mL Gentamicin. Sydney IVF Hyaluronidase is provided sterile (aseptically filtered) and is packaged in glass vials with Fluorotec coated rubber stoppers held in place with a tamper evident seal. It is available in a 5 pack carton box with each vial containing 1 mL of Sydney IVF Hvaluronidase.
    Ask a Question
    K Number
    K153290
    Device Name
    Sydney IVF Follicle Flush Buffer, Sydney IVF Fertilization Medium, Sydney IVF Cleavage Medium, Sydney IVF Blastocyst Medium
    Manufacturer
    WILLIAM A. COOK AUSTRALIA PTY LTD
    Date Cleared
    2016-01-27

    (75 days)

    Product Code
    MQL, MOL
    Regulation Number
    884.6180
    Why did this record match?
    Applicant Name (Manufacturer) :

    WILLIAM A. COOK AUSTRALIA PTY LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Sydney IVF Follicle Flush Buffer is intended for use during in vitro fertilization procedures for follicle flushing and oocyte collection. Sydney IVF Fertilization Medium is intended for use during in vitro procedures for insemination of oocytes. Sydney IVF Cleavage Medium is intended for use during in vitro fertilization procedures for culture and transfer of cleavage stage embryos. Sydney IVF Blastocyst Medium is intended for use during in vitro fertilization procedures for extended culture and transfer of embryos.
    Device Description
    The Sydney IVF Follicle Flush Buffer, Sydney IVF Fertilization Medium, Sydney IVF Cleavage Medium and Sydney IVF Blastocyst Medium are used for processing eggs and embryos during in vitro fertilization procedures. Sydney IVF Follicle Flush Buffer is used to flush the follicles during oocyte recovery. It contains Gentamicin (0.01mg/mL) and is available in 100 mL vials. Sydney IVF Fertilization Medium maintains oocytes in a 6% CO2 environment until insemination and fertilization is complete. Sydney IVF Fertilization Medium contains Humans Serum Albumin (HSA) (5 mg/mL) and Gentamicin (0.01 mg/mL). It is available in 20, 50 or 100 mL vials. Sydney IVF Cleavage Medium facilitates the first two days of embryonic growth post fertilization. Sydney IVF Cleavage Medium contains HSA (5 mg/mL) and Gentamicin (0.01 mg/mL). It is available in 20, 50 or 100 mL vials. Once an embryo has reached the Day 3 (eight-cell) stage, it is then transferred into Sydney IVF Blastocyst Medium. This medium has been metabolically balanced to maximize blastocyst development rates and is suitable for blastocyst transfer. Sydney IVF Blastocyst Medium contains HSA (5 mg/mL) and Gentamicin (0.01 mg/mL). It is available in 20 or 50 mL vials. The Sydney IVF Follicle Flush Buffer, Sydney IVF Fertilization Medium, Sydney IVF Cleavage Medium and Sydney IVF Blastocyst Medium are provided in glass vials with Fluorotec® coated rubber stoppers held in place with a tamper evident seal. These products are single use, sterile (aseptic filtration) devices.
    Ask a Question
    K Number
    K152782
    Device Name
    SYDNEY IVF SPERM MEDIUM, SYDNEY IVF SPERM GRADIENT KIT, SYDNEY IVF SPERMIENT
    Manufacturer
    WILLIAM A. COOK AUSTRALIA PTY LTD
    Date Cleared
    2015-12-21

    (87 days)

    Product Code
    MQL, MOL
    Regulation Number
    884.6180
    Why did this record match?
    Applicant Name (Manufacturer) :

    WILLIAM A. COOK AUSTRALIA PTY LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Sydney IVF Sperm Medium is intended for use during in vitro fertilization procedures to process sperm. Sydney IVF Sperm Gradient Kit is intended for use during in vitro fertilization procedures to separate motile sperm from seminal plasma. Sydney IVF Spermient is intended for use during in vitro fertilization procedures to separate motile sperm from seminal plasma.
    Device Description
    The Sydney IVF Sperm Medium, Sydney IVF Sperm Gradient Kit and Sydney IVF Spermient are used for processing sperm during in vitro fertilization procedures. Sperm Medium is used to provide a "liquid" and nutritious environment for the sperm to maintain its motility for the "swim up" procedures and the following fertilization process. The medium contains 10 mg/mL Human Serum Albumin (HSA) and 0.01 mg/mL Gentamicin. It is available in 20, 50 or 100 mL vials. Sydney IVF Sperm Gradient Kit is used to separate sperm based on density, using density gradient solutions. Sperm Gradient Kit contains both 40% density solutions and is comprised of silane coated silica particles which are diluted in a HEPES buffer. The sperm gradient has the dual purpose of enriching motile sperm populations and removing sperm inhibitory compounds normally present in the eiaculate. It contains 10 mg/mL HSA and 0.01 mg/mL Gentamicin. Sydney IVF Sperm Gradient Kit is available in 20 or 50 mL vials, packaged in a carton box, consisting of one vial filled with the 40% sperm gradient solution, and a second vial filled with the 80% sperm gradient solution. Sydney IVF Spermient is intended to separate sperm based on density, using density gradient solutions. This is achieved by diluting the Spermient into various concentrations with a HEPES buffered solution. It contains colloidal silica coated with an inert polymer (silane) and has been formulated to be isotonic. Spermient contains 10 mg/mL HSA and 0.01 mg/mL Gentamicin. It is available in 20 or 100 mL vials. The Sydney IVF Sperm Medium, Sydney IVF Sperm Gradient Kit and Sydney IVF Spermient are provided in glass vials with Fluorotec® coated rubber stoppers held in place with a tamper evident seal.. These products are single use, sterile (aseptic filtration) devices.
    Ask a Question

    Page 1 of 1