K202542 is an FDA 510(k) clearance for the Allura Vaginal Stent. This device is classified as a Stent, Vaginal (Class II - Special Controls, product code KXP).
Submitted by Pmt Corporation (Chanhassen, US). The FDA issued a Cleared decision on September 30, 2020, 28 days after receiving the submission on September 2, 2020.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.3900.
| 510(k) Number | K202542 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 02, 2020 |
| Decision Date | September 30, 2020 |
| Days to Decision | 28 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Statement |
| Product Code | KXP - Stent, Vaginal |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.3900 |