K200409 is an FDA 510(k) clearance for the Pelvital System. This device is classified as a Perineometer (Class II - Special Controls, product code HIR).
Submitted by Pelvital USA, Inc. (Minneapolis, US). The FDA issued a Cleared decision on July 10, 2020, 142 days after receiving the submission on February 19, 2020.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 884.1425.
| 510(k) Number | K200409 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 19, 2020 |
| Decision Date | July 10, 2020 |
| Days to Decision | 142 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | HIR — Perineometer |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.1425 |