MKO
4 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Falloposcope
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.1690
- Medical specialty
- Obstetrics/Gynecology
- Adverse events (MAUDE)
- 1996: 3 · 1997: 4
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| FemDx FalloView (K221965) | Femdx Medsystems, Inc. | 2023-03-17 |
| STARGATE FALLOPOSCOPY CATHETER, TRIFURCATED IRRIGATION TUBING (K974028) | Conceptus, Inc. | 1998-01-21 |
| CONCEPTUS FALLOPIAN TUBE CATHETEIZATION WITH MICROENDOSCOPY SYSTEM (K962587) | Conceptus, Inc. | 1997-01-31 |
| IMAGYN FALLOPOSCOPY SYSTEM (K963580) | Imagyn Medical, Inc. | 1997-01-31 |
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Every clearance here is in the API, with alerts when new ones post.