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510(k) Data Aggregation
K Number
K141666Device Name
FERTILIGENT SLOW RELEASE IUI CATHETER KIT
Manufacturer
FERTILIGENT, LTD
Date Cleared
2015-02-03
(225 days)
Product Code
MQF
Regulation Number
884.6110Why did this record match?
Applicant Name (Manufacturer) :
FERTILIGENT, LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Delivery of approximately 1ml of sperm into the uterus over 3-4 hours using a controlled release pump.
Device Description
The subject device is a balloon catheter for slow release intrauterine insemination. The catheter is placed in the uterus and sperm is injected through the catheter. The subject device is provided with a standard 3 ml syringe, a mechanical actuator, and a leg strap. Sperm is loaded into the syringe, and the syringe is attached to the IUI catheter. The syringe is placed in the mechanical actuator to deliver the sperm over a 3-4 hour period.
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K Number
K092579Device Name
INTRAUTERINE INSEMINATION (IUI) CATHETER
Manufacturer
FERTILIGENT, LTD
Date Cleared
2010-04-02
(228 days)
Product Code
MQF
Regulation Number
884.6110Why did this record match?
Applicant Name (Manufacturer) :
FERTILIGENT, LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Delivery of approximately 1 ml of sperm into the uterus over 3-4 hours using a controlled release pump.
Device Description
The IUI Catheter is a balloon catheter for slow release insemination. The catheter is placed in the uterus and sperm is injected through the catheter. The kit includes a standard BD 3 ml syringe and a mechanical actuator, as well as an ancillary component, a leg strap. Sperm is loaded into the syringe which is attached to the IUI catheter. The syringe is placed in a plastic, spring loaded mechanical actuator to press on the syringe plunger and deliver the sperm over a 3-4 hour period.
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