Cannula, Intrauterine Insemination
FDA product code MFD · Class II (moderate risk) · 21 CFR 884.5250 · Obstetrics/Gynecology
29510(k) clearances
0PMA approvals
1recalls
Manufacturers
- Life-Tech Intl., Inc. 4
- Marlo Surgical Technology 2
- Cook Ob/Gyn 2
- Medworks Corp. 2
- Life Technologies Corporation 2
- Select Medical Systems, Inc. 2
- A & A Medical, Inc. 2
- Cook Urological, Inc. 1
- Labotect Labor-Technik Gottingen 1
- Wallach Surgical Devices, Inc. 1
- Rocket Medical Plc 1
- Imagyn Medical, Inc. 1
- Marlow Surgical Technologies, Inc. 1
- <Genx> Intl., Inc. 1
- Ackrad Laboratories 1
- Promedex, Inc. 1
- Conceptus, Inc. 1
- Lifetek Medical, Inc. 1
- Irvine Scientific 1
- Unimar, Inc. 1
510(k) clearances
| 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 |
| K963031 | GenxcatheterMFD · Traditional | Genx Intl., Inc. | 10/21/1996SE |
| K962273 | Malleable Stylet 18 CM ME1816ST, 23 CM ME1816NSTMFD · Traditional | Marlo Surgical Technology | 07/31/1996SE |
| K940176 | Ackrad Iui Set for Intrauterine InseminationMFD · Traditional | Ackrad Laboratories | 04/23/1996SE |
| K954398 | Insemi-Cath IIMFD · Traditional | Cook Urological, Inc. | 12/19/1995SE |
| K954099 | Select IuiMFD · Traditional | Select Medical Systems, Inc. | 11/22/1995SE |
| K953719 | Human Tubal FluidMFD · Traditional | Life Technologies, Inc. | 11/06/1995SE |
| K951835 | Modified Human Tubal Fluid (MHTF) With/Without Penicillin G Dolium, With/Without…MFD · Traditional | Life Technologies, Inc. | 08/11/1995SE |
| K932993 | Intrauterine Catheter and IntroducerMFD · Traditional | Conceptus, Inc. | 01/06/1995SE |
| K921518 | Lifetek Iui CatheterMFD · Traditional | Lifetek Medical, Inc. | 05/10/1994SE |
| K931630 | Insemi-CathMFD · Traditional | Cook Ob/Gyn | 04/19/1994SE |
| K914541 | Sperm Maintenance Medium with GlycerolMFD · Traditional | Irvine Scientific | 02/03/1994SE |
| K923652 | Dulbecco's Phosphate Buffered SalineMFD · Traditional | Life-Tech Intl., Inc. | 09/07/1993SE |
| K923651 | Distilled WaterMFD · Traditional | Life-Tech Intl., Inc. | 09/07/1993SE |
| K923634 | Modified F-10 Culture MediumMFD · Traditional | Life-Tech Intl., Inc. | 09/07/1993SE |
| K923612 | Modified F-10 Culture Medium W/O HypoxanthineMFD · Traditional | Life-Tech Intl., Inc. | 09/07/1993SE |
| K914150 | Jansen-Anderson Insemination SetMFD · Traditional | Cook Ob/Gyn | 09/02/1992SE |
| K910577 | Edwards-Wallace Bourne Hall CatheterMFD · Traditional | Marlo Surgical Technology | 05/09/1991SE |
| K910317 | Uni-Sem(Tm)MFD · Traditional | Unimar, Inc. | 05/01/1991SE |
| K905764 | SeminorMFD · Traditional | Promedex, Inc. | 03/12/1991SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1713-2020 Class III | Wallace Artificial Insemination Catheter, 180 mm, Sterile, Quantity: 1 Box (10 units)…Expiration date discrepancy. Marked as 5 years. Expiration date should be 3 years. | CooperSurgical, Inc. | 02/28/2020Terminated |