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Found 15 results
510(k) Data Aggregation
K Number
K200680Device Name
Synvitro Hyadase
Manufacturer
Origio a/s, a CooperSurgical Company
Date Cleared
2020-07-17
(123 days)
Product Code
MQL
Regulation Number
884.6180Why did this record match?
Applicant Name (Manufacturer) :
Origio a/s, a CooperSurgical Company
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
SynVitro® Hyadase is for the removal of the cumulus complex and corona radiata surrounding the oocyte in preparation for ICSI.
Device Description
SynVitro® Hyadase is a modified version of the prior cleared SynVitro® Hyadase device and is used for removal of cumulus and corona radiata cells surrounding the oocytes (denudation) prior to intracytoplasmic sperm injection (ICSI).
SynVitro® Hyadase is a clear non-viscous hyaluronidase enzyme solution contained in a 2 ml transparent plastic bottles (containing 1 ml solution) with caps and provided in cardboard boxes containing five bottles. This product has a one-year shelf-life when stored as recommended and can be used for up to seven days after opening.
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K Number
K200815Device Name
VitriGuard
Manufacturer
ORIGIO a/s
Date Cleared
2020-06-25
(87 days)
Product Code
MQK
Regulation Number
884.6160Why did this record match?
Applicant Name (Manufacturer) :
ORIGIO a/s
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
VitriGuard is intended for use as a cryopreservation storage device in vitrification procedures and indicated to contain and maintain human oocytes (MII), 4-8 cell embryos and blastocyst stage embryos.
Device Description
VitriGuard is a sterile, single-use device that is intended for use as a cryopreservation storage device in vitrification procedures. The device consists of a two-piece polystyrene assembly that includes a hexagonal-shaped stick and cap. As part of the vitrification procedure, the oocytes or embryos are loaded on the tip of the stick is capped prior to plunging the device in liquid nitrogen and for subsequent storage. The tip has a trough area for loading, maintaining and securing oocytes or embryos. The stick and cap include a taper design that create a seal when assembled. Black markings at the end of the stick and the tip of the device provide visual aid for proper device orientation. All VitriGuard devices have a blue cap and the sticks are available in eight (8) translucent colors: clear, blue, green, yellow, lime green, purple, orange and pink.
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K Number
K180740Device Name
VitriGuard
Manufacturer
ORIGIO a/s
Date Cleared
2018-05-04
(43 days)
Product Code
MQK, MOK
Regulation Number
884.6160Why did this record match?
Applicant Name (Manufacturer) :
ORIGIO a/s
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
VitriGuard is a cryopreservation storage device that is intended for use in vitrification procedures to contain and maintain human 4-8 cell and blastocyst stage embryos.
Device Description
VitriGuard is a cryopreservation storage device that is intended for use in vitrification procedures to contain and maintain human 4-8 cell and blastocyst stage embryos. It is single-use, disposable, and provided sterile. The device consists of a two-piece polystyrene assembly that includes a hexagonalshaped stick and cap. As part of the vitrification procedure, the embryos to be stored are loaded on the tip, and capped prior to plunging the device in liquid nitrogen and for subsequent storage. The tip has a trough area for loading, maintaining, and securing the embryos. The stick and cap include a taper design that creates a seal when assembled. Markings at the end of the stick and the tip of the device provide visual aid for proper device orientation.
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K Number
K173624Device Name
ORIGIO® Handling without phenol red (Cat. No. 8310), ORIGIO® Handling with phenol red (Cat. No. 8311)
Manufacturer
Origio a/s
Date Cleared
2018-03-02
(98 days)
Product Code
MQL, MOL
Regulation Number
884.6180Why did this record match?
Applicant Name (Manufacturer) :
Origio a/s
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
ORIGIO® Handling™ is intended for in vitro procedures involving handling and micromanipulation of gametes and embryos outside the CO2 incubator.
Indication includes oocyte retrieval including follicle flushing, gamete (oocyte/sperm) and embryo washing, and micromanipulation procedures including Intra Cytoplasmic Sperm Injection (ICSI), assisted hatching and trophectoderm biopsy.
Device Description
ORIGIO® Handling™ is a non-viscous, ready-to-use solution providing supporting conditions for human gametes and embryos during in vitro Assisted Reproduction Technology (ART) procedures taking place outside the CO2 incubator. This product can also be used for oocyte retrieval including follicle flushing.
ORIGIO® Handling™ consists of amino acids, glucose, physiological salts, calcium lactate, sodium pyruvate, vitamins, sodium bicarbonate MOPS/HEPES, human serum albumin, and gentamicin sulfate. This product is supplied with phenol red (Cat. No. 8311) or without phenol red (Cat. No. 8310).
ORIGIO® Handling™ is a single-use device that is aseptically filled into sterilized bottles (60 and 125 ml) and has a sterility assurance level (SAL) of 103. The product is stored at 2-8℃, and if not warmed, the product can be used for up to seven days after bottle opening. Prior to use, ORIGIO® Handling™ must be pre-warmed to 37℃, except for sperm washing procedures where the product is pre-warmed to room temperature before use.
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K Number
K172197Device Name
SAGE 1-Step GM-CSF with HSA, SAGE 1-Step GM-CSF with SPS
Manufacturer
ORIGIO a/s
Date Cleared
2017-10-13
(84 days)
Product Code
MQL, MOL
Regulation Number
884.6180Why did this record match?
Applicant Name (Manufacturer) :
ORIGIO a/s
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The product is intended for in vitro culture of human embryos following fertilization until Day 5/6 of development. The media can also be used for embryo transfer.
Device Description
SAGE 1-Step™ GM-CSF with HSA and SAGE 1-Step™ GM-CSF with SPS are assisted reproduction embryo culture media products consisting agents, physiological salts, energy substrates, amino acids, antibiotics, protein supplements (HSA or SPS), and granulocyte-macrophage colony-stimulating factor (GM-CSF, 2 ng/ml). These devices are aseptically filtered (sterility assurance level of 10 %), and supplied in 3 ml glass vials. They are tested for pH, osmolality, embryotoxicity, endotoxin, sterility, and GM-CSF concentration and potency before lot release. These devices have a shelf-life of 16 weeks, and can be used for up to seven days after vial opening when stored at 2-8°C.
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K Number
K161547Device Name
Transem and EchoGen Embryo Transfer Catheters
Manufacturer
ORIGIO A/S
Date Cleared
2017-03-09
(279 days)
Product Code
MQF, MOF
Regulation Number
884.6110Why did this record match?
Applicant Name (Manufacturer) :
ORIGIO A/S
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Transem and EchoGen™ are catheters with angled or spherical tips for embryo transfer into the uterine cavity in the treatment of infertility.
The Transem Stylets are intended to assist the insertion of the Transem or EchoGen™ catheters where the passage through the cervix is impeded.
Device Description
The Transem and EchoGen™ are Embryo Transfer Catheters with various angled or spherical tips and various lengths. The EchoGen™ variants are designed to be visible under ultrasound imaging. Stylets to aid in the insertion of the embryo catheters are also available.
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K Number
K162833Device Name
VitriGuard
Manufacturer
ORIGIO A/S
Date Cleared
2017-02-16
(128 days)
Product Code
MQK
Regulation Number
884.6160Why did this record match?
Applicant Name (Manufacturer) :
ORIGIO A/S
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
VitriGuard is a cryopreservation storage device that is intended for use in vitrification procedures to contain and maintain human 4-8 cell and blastocyst stage embryos.
Device Description
VitriGuard is a cryopreservation storage device that is intended for use in vitrification procedures to contain and maintain human 4-8 cell and blastocyst stage embryos. The VitriGuard device is composed of a two-piece polystyrene assembly that includes a hexagonal shaped stick and cap. As part of the vitrification procedure, the embryos to be stored are loaded on the tip, also referred to as the leaf, and capped with a pre-cooled cap for subsequent storage following vitrification. The leaf has a trough area for loading. maintaining, and securing the embryos. The stick and cap include a taper design that creates a hermetic seal, forming a closed system. Markings at the stick and the tip of the device provide visual aid for proper device orientation. The device is provided sterile and is for single use only. The VitriGuard has been designed as a cryopreservation storage device to maintain the integrity of human 4-8 cell and blastocyst stage embryos throughout the cooling. storage, and warming processes.
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K Number
K153267Device Name
ORIGIO Gradient 100, ORIGIO Gradient 90, ORIGIO Gradient 40/80, ORIGIO Sperm Wash
Manufacturer
ORIGIO A/S
Date Cleared
2016-07-22
(253 days)
Product Code
MQL
Regulation Number
884.6180Why did this record match?
Applicant Name (Manufacturer) :
ORIGIO A/S
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
ORIGIO® Sperm Wash is intended for washing of spermatozoa, the isolation of motile viable sperm by swim-up method, dilution of ORIGIO gradients, and holding sperm for IUI procedure
ORIGIO® Gradient™ 100, ORIGIO® Gradient™ 90 and ORIGIO® Gradient™ 40/80 are for separation of motile sperm from the ejaculate by the density gradient method.
Device Description
ORIGIO® Sperm Wash and ORIGIO® Gradient™ devices are for separation of motile sperm from semen and handling of sperm. These devices are based on the same formulation, but differ in the content of Human Serum Albumin (HSA), NaCl, bicarbonate, and silane silica. The silane silica generates the density, thus it is an ingredient in the ORIGIO® Gradient™ devices only and is not present in ORIGIO® Sperm Wash. All subject devices, except ORIGIO® Gradient™ 100, contain gentamicin and HSA.
The subject devices are aseptically filtered, colorless solutions. ORIGIO® Gradient™ devices are viscous while ORIGIO® Sperm Wash is non-viscous. They are contained in transparent polyethylene terephthalate glycol (PETG) bottles with high density polyethylene (HDPE) closures, available in card board boxes, individually labeled and with instruction for use provided as a package insert.
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K Number
K152932Device Name
BlastGen
Manufacturer
ORIGIO A/S
Date Cleared
2016-02-29
(147 days)
Product Code
MQL, MOL
Regulation Number
884.6180Why did this record match?
Applicant Name (Manufacturer) :
ORIGIO A/S
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
BlastGen™ is for the culture of embryos from the 4-8 cell stage through to the blastocyst stage. BlastGen™ can also be used for embryo transfer.
Device Description
BlastGen™ is based on ORIGIO® Sequential Blast™ (K133387) with the supplement of Leukine (Sargramostim) granulocyte macrophage colony-stimulating factor (GM-CSF).
BlastGen™ is a colorless, non-viscous solution contained in 3mL transparent glass bottles with white polypropylene caps, available in a single piece card board box, individually labeled and with instruction for use provided as a package insert. BlastGen™ is a ready to use by professionals for assisted reproduction.
BlastGen™ is quality control tested before release for pH, sterility, Mouse Embryo Assay, endotoxin, osmolality, GM-CSF concentration (by ELISA), GM-CSF potency (TF-1 cell assay) and human serum albumin (HSA) concentration (by ELISA).
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K Number
K140317Device Name
EMBRYOGEN
Manufacturer
ORIGIO A/S
Date Cleared
2014-06-16
(126 days)
Product Code
MQL
Regulation Number
884.6180Why did this record match?
Applicant Name (Manufacturer) :
ORIGIO A/S
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
EmbryoGen® is for culture of human embryos until the 2-8 cell stage. EmbryoGen® can also be used for embryo transfer at day 2 or 3.
Device Description
EmbryoGen® (1204) is a modification of EmbryoGen® (1203) (K120136), where the base medium has been changed from EmbryoAssist® (K080473) to the new ORIGIO Sequential Cleav™ (K133912) medium. EmbryoGen® (1204) contains GM-CSF (Granulocyte macrophage- colony stimulating factor), in the same concentration as EmbryoGen® (1203). EmbryoGen® (1204) is an aseptically filtered, colorless, non viscous solution, which is ready to use by professionals within assisted reproduction. EmbryoGen® (1204) is contained in 3 ml transparent glass bottles with white polypropylene caps, available in a single piece card board box, individually labeled and with instruction for use provided as a package insert.
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