`The Inseminator' (Proposed)
FDA 510(k) K984306 · Wallach Surgical Devices, Inc.
510(k) numberK984306
Submission
- Device name
- `The Inseminator' (Proposed)
- Applicant
- Wallach Surgical Devices, Inc.
Orange, CT, US - Received
- December 2, 1998
- Decision date
- March 1, 1999
- 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 |
| 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 |
More from Genx Intl., Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K021224 | Endocervical Block NeedleHEE · Traditional | 07/12/2002SE |
| K020711 | Wallach Loop ElectrodeGEI · Traditional | 06/03/2002SE |
| K000768 | Wallach Quantum 500 Electrosurgical GeneratorEKZ · Traditional | 04/11/2000SE |
| K992736 | Wallach's Ultimate Reusable, Plastic Vaginal SpeculumHIB · Traditional | 09/29/1999SE |
| K991669 | PMS 750 FingerswitchGEI · Traditional | 08/12/1999SE |
| K983840 | Wallach Quantum 500 Electrosurgical Generator (Proposed)HGI · Traditional | 05/20/1999SE |
| K983208 | Wallach Quantum 500 Electrosurgical GeneratorGEI · Traditional | 02/22/1999SE |
| K963653 | Wallach Quantum 2000 Electrosurgical SystemHGI · Traditional | 06/11/1997SE |
| K963348 | Wallach Integration UnitHGI · Traditional | 03/19/1997SE |
| K950630 | Wallach Digital Imaging SystemLMB · Traditional | 11/22/1995SE |
Questions and answers
When was `The Inseminator' (Proposed) cleared by the FDA?
`The Inseminator' (Proposed) (K984306) received a 510(k) decision of Substantially Equivalent on March 1, 1999, 89 days after the submission was received.
What is the product code of K984306?
The FDA product code is MFD – Cannula, Intrauterine Insemination, a Class II (moderate risk) device regulated under 21 CFR 884.5250.