K232579 is an FDA 510(k) clearance for the Twoplus Applicator. This device is classified as a At Home Intravaginal Insemination System (Class II - Special Controls, product code QYZ).
Submitted by Hannah Life Technologies Pte , Ltd. (Singapore, SG). The FDA issued a Cleared decision on December 21, 2023, 118 days after receiving the submission on August 25, 2023.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.6110. To Deliver Semen To The Vaginal Canal For Insemination..
| 510(k) Number | K232579 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 25, 2023 |
| Decision Date | December 21, 2023 |
| Days to Decision | 118 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Statement |
| Product Code | QYZ - At Home Intravaginal Insemination System |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.6110 |
| Definition | To Deliver Semen To The Vaginal Canal For Insemination. |