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Found 13 results
510(k) Data Aggregation
K Number
K021438Device Name
INSEMINATION CATHETER, MODEL 320301
Manufacturer
LABOTECT LABOR-TECHNIK GOTTINGEN
Date Cleared
2002-07-16
(71 days)
Product Code
MFD
Regulation Number
884.5250Why did this record match?
Product Code :
MFD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The catheter is used for intrauterine insemination.
Device Description
The Insemination Catheters are used for transferring sperms into the uterine cavity. They have a well rounded tip and two distal side ports. The insemination fluid is introduced using a syringe attached to the proximal luer. The material used in these devices is Polypropylene. Biocompatibility is assured according to ISO 10993.
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K Number
K012935Device Name
THECURVE, ITEM 507
Manufacturer
SELECT MEDICAL SYSTEMS, INC.
Date Cleared
2001-10-11
(41 days)
Product Code
MFD
Regulation Number
884.5250Why did this record match?
Product Code :
MFD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
As the Select IUI® (predicate device), TheCurve™ (new device) is a single use, sterile, disposable, flexible catheter designed to be used for intrauterine artificial insemination.
Device Description
TheCurve, such as the Select IUI, comprises a long clear polyethylene tube that is tightly surrounded on three quarters of its proximal length by an outer, clear polypropylene sheath. This leaves 4.5 cm of the inner polyethylene tube exposed at the distal end of the device. The proximal inner tube and outer sheath circumferences are molded directly onto the distal end of a luer lock hub so that only the lumen of the inner tube can provide a channel for flow. This design results in a single-channel catheter with two segments each having different degrees of flexibility. The extreme distal tip of TheCurve™ is open as compared to the extreme distal tip of the Select IUI® which is closed and has two side openings. Both TheCurve and Select IUI have six (6) coloured graduation markings placed at 5, 6, 7, 8, 9, and 10 cm distance from the extreme distal tip of the catheter. The distal portion of TheCurve is curved while the distal portion of the Select IUI is straight.
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K Number
K984306Device Name
`THE INSEMINATOR' (PROPOSED)
Manufacturer
WALLACH SURGICAL DEVICES, INC.
Date Cleared
1999-03-01
(89 days)
Product Code
MFD
Regulation Number
884.5250Why did this record match?
Product Code :
MFD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The 'Inseminator' is used for intrauterine artificial insemination procedures utilizing washed spermatozoa or semen. The 'Inseminator' is not intended for intrafallopian tube or in vitro fertilization (IVF) procedures.
Device Description
The malleable catheter of Wallach's 'Inseminator' includes the fine, smoothed tip, with a flared proximal end. Insemination fluid (washed sperm) is introduced into the uterine cavity using a syringe attached to the proximal luer.
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K Number
K982630Device Name
MEDWORKS VISUALIZATION INSEMINATION CATHETER
Manufacturer
MEDWORKS CORP.
Date Cleared
1999-01-14
(170 days)
Product Code
MFD
Regulation Number
884.5250Why did this record match?
Product Code :
MFD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
For use in intrauterine artificial insemination procedures using washed spermatozoa or semen.
Device Description
Malleable catheter with distal side ports and a lumen which can accommodate a fiberoptic device to allow visualization of the interior of the uterus. Allows physician to confirm placement of insemination fluid in the uterine cavity.
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K Number
K982628Device Name
MEDWORKS INSEMINATION CATHETER
Manufacturer
MEDWORKS CORP.
Date Cleared
1998-08-21
(24 days)
Product Code
MFD
Regulation Number
884.5250Why did this record match?
Product Code :
MFD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
For use in intrauterine artificial insemination procedures using washed spermatozoa or semen.
Device Description
Malleable catheter with distal side ports and balloon to help position the catheter at the uterus. Balloon is filled with saline: insemination fluid is introduced using a syringe attached to the proximal luer.
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K Number
K980061Device Name
EMBRYON INTRAUTERINE INSEMINATION CATHETER, EMRYON SOFT INTRAUTERINE INSEMINATION CATHETER, STYLET FOR EMBRYON INTRAUTER
Manufacturer
ROCKET MEDICAL PLC
Date Cleared
1998-03-02
(54 days)
Product Code
MFD
Regulation Number
884.5250Why did this record match?
Product Code :
MFD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
EMBRYON® Intra-uterine Insemination Cathetors are purpose designed for the introduction of washed spermatazon into the uterus.
Device Description
EMBRYON® Intra-uterine Insemination Catheters
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K Number
K972823Device Name
MINI-EMBRYON INTRA UTERINE INSEMINATION CATHETER
Manufacturer
A & A MEDICAL, INC.
Date Cleared
1997-10-10
(72 days)
Product Code
MFD
Regulation Number
884.5250Why did this record match?
Product Code :
MFD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Mini Embryon Intrauterine Insemination catheter allows the sperm to bypass the cervix so that an increased number can reach the Uterine cavity and subsequently the fallopian tubes. This catheter is not intended for assisted reproduction procedures.
Device Description
The Mini Embryon IUI is a 5Fr Intrauterine Inseminator made of clear polyethylene, 18 cm in length, with an OD of 1.6 mm and an ID of 1.0 mm. A 5 cm distal segment with double side eyes and a rounded tip insures a very smooth entry with minimal disturbance to the endometrial bed. This is complemented with 11 cm of marked catheter shaft with 7 Fr in diameter for better and more secure handling. A proximal Luer Lock allows for connection with a syringe. It is to be supplied in two versions, Soft & Hard.
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K Number
K972245Device Name
TOM CAT F.L., TOM CAT S.L.
Manufacturer
A & A MEDICAL, INC.
Date Cleared
1997-08-06
(51 days)
Product Code
MFD
Regulation Number
884.5250Why did this record match?
Product Code :
MFD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The TomCat allows the sperm to bypass the cervix so that an increased number can reach the Uterine cavity and subsequently the fallopian tubes, which may increase the pregnancy rate in couples with unexplained infertility
Device Description
The TomCat IUI catheter is a 3 ½ french catheter with a length of 5 ½ ". This catheter expands in size in the proximal area to accommodate a syringe tip. It is made out of propylene of class VI Grade.
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K Number
K970750Device Name
MICROSPAN INSEMINATION SYSTEM
Manufacturer
IMAGYN MEDICAL, INC.
Date Cleared
1997-05-05
(63 days)
Product Code
MFD
Regulation Number
884.5250Why did this record match?
Product Code :
MFD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Used for intrauterine insemination. The MicroSpan Delivery Catheter is designed to fit through the larger diameter MicroSpan Access Catheter for delivery of washed spermatozoa to the uterine cavity or for laparoscopic instillation and/or aspiration of media. Laparoscopically, the device is specifically intended for use to aspirate ascitic fluids, aspirate fluid from the cul-de-sac for cytologic screening and bacteriologic cultures, irrigation and aspiration of larger volumes of fluid from ovarian tumors, irrigation and rinsing of the operative field, aspiration of bloody fluid resulting from a tubal pregnancy or post operative bleeding, and instillation of sterile saline or Ringer's solution.
Device Description
The MicroSpan Insemination System is a sterile device consisting of two components: the MicroSpan Access Catheter (introducer) and the MicroSpan Delivery Catheter. The MicroSpan Insemination System is designed to be introduced through the MicroSpan Hysteroscope Sheath for intrauterine insemination procedures or introduced through the operative channel of a laparoscope for laparoscopic instillation and/or aspiration of media.
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K Number
K964848Device Name
WALLACE ARTIFICIAL INSEMINATION CATHETER - 8CM/18CM
Manufacturer
MARLOW SURGICAL TECHNOLOGIES, INC.
Date Cleared
1997-01-16
(44 days)
Product Code
MFD
Regulation Number
884.5250Why did this record match?
Product Code :
MFD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Family of Wallace Artificial Insemination Catheter are sterile single-use device intended for insertion of catheters and introduction of washed spermatozoa into the uterine cavity.
Device Description
The Family of Wallace Artificial Insemination Catheter are sterile single-use device intended for insertion of catheters and introduction of washed spermatozoa into the uterine cavity.
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