K100662 is an FDA 510(k) clearance for the FEMVUE CORNUAL BALLOON CATHETER. 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 April 7, 2010, 30 days after receiving the submission on March 8, 2010.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.4530.
| 510(k) Number | K100662 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 08, 2010 |
| Decision Date | April 07, 2010 |
| Days to Decision | 30 days |
| Submission Type | Special |
| 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 |