K221965 is an FDA 510(k) clearance for the FemDx FalloView. This device is classified as a Falloposcope (Class II - Special Controls, product code MKO).
Submitted by Femdx Medsystems, Inc. (Santa Clara, US). The FDA issued a Cleared decision on March 17, 2023, 255 days after receiving the submission on July 5, 2022.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.1690.
| 510(k) Number | K221965 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 05, 2022 |
| Decision Date | March 17, 2023 |
| Days to Decision | 255 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
| Product Code | MKO - Falloposcope |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.1690 |