K233689 is an FDA 510(k) clearance for the Hope&Her Vaginal Dilators. This device is classified as a Dilator, Vaginal (Class II - Special Controls, product code HDX).
Submitted by Lujena, Inc. (El Cajon, US). The FDA issued a Cleared decision on May 2, 2024, 167 days after receiving the submission on November 17, 2023.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.3900.
| 510(k) Number | K233689 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 17, 2023 |
| Decision Date | May 02, 2024 |
| Days to Decision | 167 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Statement |
| Product Code | HDX — Dilator, Vaginal |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.3900 |