Uni-Sem(Tm)
FDA 510(k) K910317 · Unimar, Inc.
510(k) numberK910317
Submission
- Device name
- Uni-Sem(Tm)
- Applicant
- Unimar, Inc.
Wilton, CT, US - Received
- January 24, 1991
- Decision date
- May 1, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
|---|---|---|
| K932432 | Kronner Reinforcing StyletteLKF · Traditional | 04/12/1994SE |
| K920803 | HSG TrayHIB · Traditional | 10/19/1992SEKD |
| K904473 | Kronner ManipujectorHES · Traditional | 12/14/1990SE |
| K895659 | Hui Mini-FlexHIG · Traditional | 12/19/1989SE |
| K895403 | Aspirette Endocervical AspiratorHFC · Traditional | 11/29/1989SE |
| K894264 | KDF-2.3HDR · Traditional | 08/15/1989SE |
| K890848 | Cervex-BrushHHT · Traditional | 05/11/1989SE |
| K854415 | Endometrial PipelleHHK · Traditional | 03/13/1986SE |
| K810291 | Sterile/Disposable HSG TrayEYY · Traditional | 03/18/1981SE |
Questions and answers
When was Uni-Sem(Tm) cleared by the FDA?
Uni-Sem(Tm) (K910317) received a 510(k) decision of Substantially Equivalent on May 1, 1991, 97 days after the submission was received.
What is the product code of K910317?
The FDA product code is MFD – Cannula, Intrauterine Insemination, a Class II (moderate risk) device regulated under 21 CFR 884.5250.