Sperm Maintenance Medium with Glycerol
FDA 510(k) K914541 · Irvine Scientific
510(k) numberK914541
Submission
- Device name
- Sperm Maintenance Medium with Glycerol
- Applicant
- Irvine Scientific
Santa Ana, CA, US - Received
- October 11, 1991
- Decision date
- February 3, 1994
- 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 |
More from Marlow Surgical Technologies, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K160006 | Vit Kit-Freeze Oocytes, Embryos and PN zygotes Vitrification Freeze Kit, Vit Kit-Thaw…MQL · Traditional | 05/04/2016SE |
| K900316 | Modified Ham's F-10 Medium and Medium-HepesHDR · Traditional | 04/16/1990SE |
| K894432 | Modified Ham's F-10 W/AlbuminHDR · Traditional | 09/22/1989SE |
| K894405 | HTF with Albumin (Catalog No. 9994)HDR · Traditional | 09/22/1989SE |
| K874668 | Sperm Washing Medium #9983 & Modified #9984HDR · Traditional | 03/31/1988SE |
| K872203 | Cat. #9972 Refrigeration Medium (Test Yolk Buffer)HDR · Traditional | 08/14/1987SE |
| K872088 | Freezing Medium (Test Yolk Buffer W/Glycerol)HDR · Traditional | 08/14/1987SE |
| K872102 | Sperm Washing Medium #9932HDR · Traditional | 07/16/1987SE |
| K871577 | HTF Medium and Modified HTF Medium-HepesHDR · Traditional | 07/15/1987SE |
| K861188 | Sperm Capacitation MediumHDR · Traditional | 01/06/1987SE |
Questions and answers
When was Sperm Maintenance Medium with Glycerol cleared by the FDA?
Sperm Maintenance Medium with Glycerol (K914541) received a 510(k) decision of Substantially Equivalent on February 3, 1994, 846 days after the submission was received.
What is the product code of K914541?
The FDA product code is MFD – Cannula, Intrauterine Insemination, a Class II (moderate risk) device regulated under 21 CFR 884.5250.