Mini-Embryon Intra Uterine Insemination Catheter
FDA 510(k) K972823 · A & A Medical, Inc.
510(k) numberK972823
Submission
- Device name
- Mini-Embryon Intra Uterine Insemination Catheter
- Applicant
- A & A Medical, Inc.
Alpharetta, GA, US - Received
- July 30, 1997
- Decision date
- October 10, 1997
- 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 |
| K980061 | Embryon Intrauterine Insemination Catheter, Emryon Soft Intrauterine Insemination…MFD · Traditional | Rocket Medical Plc | 03/02/1998SE |
| 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 |
More from Genx Intl., Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K013491 | HSG Catheter Set, 5F Model RGS0947, HSG Catheter Set, 7F, Model R65-948LKF · Traditional | 11/19/2001SE |
| K013437 | SF SH Catheter, Model R65-945LKF · Traditional | 11/19/2001SE |
| K003949 | Tacker, Model R65-933OCW · Traditional | 07/25/2001SE |
| K011512 | Mmodification to LaminariaHDY · Traditional | 07/09/2001SE |
| K010510 | Balloon Cannula, Short, Model R65-985; Balloon Cannula, Long, Model R65-985-1HET · Traditional | 05/16/2001SE |
| K010789 | Cannula, Surgical General & Plastic Surgery, MODELR65-995, R65-995-1, R65-995-2…GCJ · Traditional | 04/27/2001SE |
| K010056 | Uterine Manipulator Injector Cannula, Sterile, Model R 57-450LKF · Traditional | 02/01/2001SE |
| K000027 | Insufflation Needle, Model R65-933HIF · Traditional | 04/03/2000SE |
| K994256 | Suction Irrigation Trumpet Valve Set, Model Q65-823GCJ · Traditional | 02/03/2000SE |
| K974038 | The Aspirator, 6FT Silicone Tubing, Metal Tubing Adapter, Glass Reservoir, Neoprene…JCX · Traditional | 05/11/1998SE |
Questions and answers
When was Mini-Embryon Intra Uterine Insemination Catheter cleared by the FDA?
Mini-Embryon Intra Uterine Insemination Catheter (K972823) received a 510(k) decision of Substantially Equivalent on October 10, 1997, 72 days after the submission was received.
What is the product code of K972823?
The FDA product code is MFD – Cannula, Intrauterine Insemination, a Class II (moderate risk) device regulated under 21 CFR 884.5250.