K241693 is an FDA 510(k) clearance for the FemChec Controlled Saline-Air Device (FCD-250), 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 September 6, 2024, 86 days after receiving the submission on June 12, 2024. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.4530.
| 510(k) Number | K241693 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | June 12, 2024 |
| Decision Date | September 06, 2024 |
| 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 |