K083690 is an FDA 510(k) clearance for the FEMVUE(TM) CATHETER SYSTEM. This device is classified as 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 June 23, 2009, 193 days after receiving the submission on December 12, 2008.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.4530.
| 510(k) Number | K083690 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 12, 2008 |
| Decision Date | June 23, 2009 |
| Days to Decision | 193 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 |