Falloposcope
FDA product code MKO · Class II (moderate risk) · 21 CFR 884.1690 · Obstetrics/Gynecology
4510(k) clearances
0PMA approvals
0recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K221965 | FemDx FalloViewMKO · Traditional | Femdx Medsystems, Inc. | 03/17/2023SE |
| K974028 | Stargate Falloposcopy Catheter, Trifurcated Irrigation TubingMKO · Traditional | Conceptus, Inc. | 01/21/1998SE |
| K963580 | Imagyn Falloposcopy SystemMKO · Traditional | Imagyn Medical, Inc. | 01/31/1997SE |
| K962587 | Conceptus Fallopian Tube Catheteization with Microendoscopy SystemMKO · Traditional | Conceptus, Inc. | 01/31/1997SE |