Genxcatheter
FDA 510(k) K963031 · Genx Intl., Inc.
510(k) numberK963031
Submission
- Device name
- Genxcatheter
- Applicant
- Genx Intl., Inc.
Madison, CT, US - Received
- August 5, 1996
- Decision date
- October 21, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- MFD – Cannula, Intrauterine Insemination
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.5250
- Specialty
- Obstetrics/Gynecology
Other 510(k)s with product code MFD
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K021438 | Insemination Catheter, Model 320301MFD · Abbreviated | Labotect Labor-Technik Gottingen | 07/16/2002SE |
| K012935 | Thecurve, Item 507MFD · Traditional | Select Medical Systems, Inc. | 10/11/2001SE |
| K984306 | `The Inseminator' (Proposed)MFD · Traditional | Wallach Surgical Devices, Inc. | 03/01/1999SE |
| K982630 | Medworks Visualization Insemination CatheterMFD · Traditional | Medworks Corp. | 01/14/1999SE |
| K982628 | Medworks Insemination CatheterMFD · Traditional | Medworks Corp. | 08/21/1998SE |
| K980061 | Embryon Intrauterine Insemination Catheter, Emryon Soft Intrauterine Insemination…MFD · Traditional | Rocket Medical Plc | 03/02/1998SE |
| K972823 | Mini-Embryon Intra Uterine Insemination CatheterMFD · Traditional | A & A Medical, Inc. | 10/10/1997SE |
| K972245 | Tom Cat F.L., Tom Cat S.L.MFD · Traditional | A & A Medical, Inc. | 08/06/1997SE |
| K970750 | Microspan Insemination SystemMFD · Traditional | Imagyn Medical, Inc. | 05/05/1997SE |
| K964848 | Wallace Artificial Insemination Catheter - 8CM/18CMMFD · Traditional | Marlow Surgical Technologies, Inc. | 01/16/1997SE |
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| K092578 | Lifeglobal Protein SupplementMQL · Traditional | 04/05/2010SE |
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| K080395 | Sunivf DishesMQK · Traditional | 08/13/2008SE |
| K070689 | LG Sperm FreezingMQL · Traditional | 07/03/2007SE |
| K053552 | Global Fertilization, Embryo Culture and Transfer MediaMQL · Traditional | 05/19/2006SE |
| K053551 | Micromanipulation Media System, LG Hyaluronidase and LG Paraffin OilMQL · Traditional | 05/09/2006SE |
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Questions and answers
When was Genxcatheter cleared by the FDA?
Genxcatheter (K963031) received a 510(k) decision of Substantially Equivalent on October 21, 1996, 77 days after the submission was received.
What is the product code of K963031?
The FDA product code is MFD – Cannula, Intrauterine Insemination, a Class II (moderate risk) device regulated under 21 CFR 884.5250.