K211959 is an FDA 510(k) clearance for the Milli Vaginal Dilator. This device is classified as a Dilator, Vaginal (Class II - Special Controls, product code HDX).
Submitted by Materna Medical (Mountain View, US). The FDA issued a Cleared decision on December 1, 2021, 160 days after receiving the submission on June 24, 2021.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.3900.
| 510(k) Number | K211959 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 24, 2021 |
| Decision Date | December 01, 2021 |
| Days to Decision | 160 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
| Product Code | HDX — Dilator, Vaginal |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.3900 |