Embryon Intrauterine Insemination Catheter, Emryon Soft Intrauterine Insemination Catheter, Stylet for Embryon Intrauter
FDA 510(k) K980061 · Rocket Medical Plc
510(k) numberK980061
Submission
- Device name
- Embryon Intrauterine Insemination Catheter, Emryon Soft Intrauterine Insemination Catheter, Stylet for Embryon Intrauter
- Applicant
- Rocket Medical Plc
Stamford, CT, US - Received
- January 7, 1998
- Decision date
- March 2, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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 |
| 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 |
| K963031 | GenxcatheterMFD · Traditional | Genx Intl., Inc. | 10/21/1996SE |
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| K052365 | Cervineedle Disposable Cartridge SyringeHEE · Traditional | 10/17/2005SE |
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Questions and answers
When was Embryon Intrauterine Insemination Catheter, Emryon Soft Intrauterine Insemination Catheter, Stylet for Embryon Intrauter cleared by the FDA?
Embryon Intrauterine Insemination Catheter, Emryon Soft Intrauterine Insemination Catheter, Stylet for Embryon Intrauter (K980061) received a 510(k) decision of Substantially Equivalent on March 2, 1998, 54 days after the submission was received.
What is the product code of K980061?
The FDA product code is MFD – Cannula, Intrauterine Insemination, a Class II (moderate risk) device regulated under 21 CFR 884.5250.