K223866 is an FDA 510(k) clearance for the Carevix™ Suction Cervical Stabilizer. 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 January 25, 2023, 33 days after receiving the submission on December 23, 2022.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.4530.
| 510(k) Number | K223866 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 23, 2022 |
| Decision Date | January 25, 2023 |
| Days to Decision | 33 days |
| Submission Type | Special |
| 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 |