K173351 is an FDA 510(k) clearance for the Panpac Flexi Shelf Pessary, a Pessary, Vaginal (Class II — Special Controls, product code HHW), submitted by Panpac Medical Corporation (Shi-Chih Dist., TW). The FDA issued a Cleared decision on October 31, 2018, 371 days after receiving the submission on October 25, 2017. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.3575.
| 510(k) Number | K173351 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | October 25, 2017 |
| Decision Date | October 31, 2018 |
| Days to Decision | 371 days |
| Submission Type | Abbreviated |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Statement |
| Product Code | HHW — Pessary, Vaginal |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 884.3575 |