K231875 is an FDA 510(k) clearance for the Vaginal Tactile Ultrasound Imager, a Perineometer (Class II — Special Controls, product code HIR), submitted by Advanced Tactile Imaging, Inc. (Ewing, US). The FDA issued a Cleared decision on February 22, 2024, 241 days after receiving the submission on June 26, 2023. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.1425.
| 510(k) Number | K231875 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | June 26, 2023 |
| Decision Date | February 22, 2024 |
| Days to Decision | 241 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
| Product Code | HIR — Perineometer |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 884.1425 |