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510(k) Data Aggregation
K Number
K171625Device Name
Single Lumen Ovum Aspiration Needles
Manufacturer
Willian A. Cook Australia Pty Ltd
Date Cleared
2018-01-12
(224 days)
Product Code
MQE, MOE
Regulation Number
884.6100Why did this record match?
Applicant Name (Manufacturer) :
Willian A. Cook Australia Pty Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Single Lumen Ovum Aspiration Needles are used for laparoscopic or ultrasound guided transvaginal aspiration and flushing of oocytes from ovarian follicles for patients undergoing Assisted Reproductive procedures.
Device Description
Single Lumen Ovum Aspiration Needles consist of a stainless-steel needle with a manipulating handle which may be connected to a fluorinated ethylene-propylene (FEP) or polytetrafluorethylene (PTFE) tube, which in turn is connected to a Silicone stopper (bung). The stopper has a Luer lock fitting directly to the stopper or connected to a length of tube to allow connection to a vacuum pump which provides aspiration suction. The stopper is placed in a 14mL test tube which acts as a collection reservoir. Needles are available in 16 to 21 gauge sizes and lengths from 25 to 35 cm. Needles have an echogenic tip that enhances the visualization of the needle tip under ultrasound. The Single Lumen Ovum Aspiration Needles are sterile and single-use devices.
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K Number
K152682Device Name
Sydney IVF Cryopreservation Kit, Sydney IVF Thawing Kit
Manufacturer
WILLIAN A. COOK AUSTRALIA PTY LTD
Date Cleared
2016-05-05
(230 days)
Product Code
MQL, MOL
Regulation Number
884.6180Why did this record match?
Applicant Name (Manufacturer) :
WILLIAN A. COOK AUSTRALIA PTY LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Sydney IVF Cryopreservation Kit is intended for use during in vitro fertilization procedures for cryopreservation of 1-cell to 8-cell embryos.
Sydney IVF Thawing Kit is intended for use during in vitro fertilization procedures for thawing of 1-cell to 8-cell embryos.
Device Description
The Sydney IVF Cryopreservation and Thawing Kits are intended for cryopreservation and thawing of 1-cell to 8-cell human embryos. The Sydney IVF Cryopreservation and Thawing Kits provide users with the ability to cryopreserve supernumerary embryos created during the in vitro fertilization procedure and then to thaw them for use at a future point in time.
The Sydney IVF Cryopreservation Kit consists of three solutions containing increasing concentrations of cryoprotectant (both propanediol and sucrose are used). These buffers were designed to be used sequentially in order to remove water from embryos prior to cryopreservation. The removal of water prevents ice crystal formation inside the embryo thereby limiting damage and improving viability. It contains 12 mg/mL Human Serum Albumin (HSA) and 0.01mg/mL Gentamicin. Sydney IVF Cryopreservation Kit is designed for use with Sydney IVF Thawing Kit.
The Sydney IVF Thawing Kit consists of four solutions with decreasing concentrations of cryoprotectants (propanediol and sucrose) which are used sequentially throughout the thawing process. It contains 12 mg/mL Human Serum Albumin (HSA) and 0.01mg/mL Gentamicin. It is designed for use with Sydney IVF Cryopreservation Kit.
Sydney IVF Cryopreservation and Thawing Kits are provided in glass vials with Fluorotec coated rubber stoppers held in place with a tamper evident seal. Sydney IVF Cryopreservation Kit is packaged in a carton box containing 2 x 10mL and 1 x 20mL solutions per kit. The Sydney IVF Thawing Kit is packaged in a carton box containing 4 x 10mL solutions per kit.
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