K133799 is an FDA 510(k) clearance for the THERMEDX FLUID MANAGMENT SYSTEM. This device is classified as a Insufflator, Hysteroscopic (Class II - Special Controls, product code HIG).
Submitted by Thermedx, LLC (Solon, US). The FDA issued a Cleared decision on June 20, 2014, 189 days after receiving the submission on December 13, 2013.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.1700.
| 510(k) Number | K133799 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 13, 2013 |
| Decision Date | June 20, 2014 |
| Days to Decision | 189 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
| Product Code | HIG - Insufflator, Hysteroscopic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.1700 |