K110288 is an FDA 510(k) clearance for the FEMVUE SALINE-AIR DEVICE, a Cannula, Manipulator/injector, Uterine (Class II — Special Controls, product code LKF), submitted by Femasys, Inc. (Suwanee, US). The FDA issued a Cleared decision on April 28, 2011, 86 days after receiving the submission on February 1, 2011. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.4530.
| 510(k) Number | K110288 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | February 01, 2011 |
| Decision Date | April 28, 2011 |
| Days to Decision | 86 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
| Product Code | LKF — Cannula, Manipulator/injector, Uterine |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 884.4530 |