K093904 is an FDA 510(k) clearance for the GLENVEIGH VAGINAL TAMPONADE BALLOON CATHETER, a Instrument, Manual, Specialized Obstetric-gynecologic (Class II — Special Controls, product code KNA), submitted by Glenveigh Surgical, LLC (Swanee, US). The FDA issued a Cleared decision on April 14, 2010, 113 days after receiving the submission on December 22, 2009. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.4530.
| 510(k) Number | K093904 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | December 22, 2009 |
| Decision Date | April 14, 2010 |
| Days to Decision | 113 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
| Product Code | KNA — Instrument, Manual, Specialized Obstetric-gynecologic |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 884.4530 |