K203820 is an FDA 510(k) clearance for the ASPIVIX v1.1 Cervical Suction Tenaculum. This device is classified as a Tenaculum, Uterine (Class II - Special Controls, product code HDC).
Submitted by Aspivix SA (Renens, CH). The FDA issued a Cleared decision on August 17, 2021, 231 days after receiving the submission on December 29, 2020.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.4530.
| 510(k) Number | K203820 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 29, 2020 |
| Decision Date | August 17, 2021 |
| Days to Decision | 231 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
| Product Code | HDC - Tenaculum, Uterine |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.4530 |