K091939 is an FDA 510(k) clearance for the THERMEDX PRODIGY FLUID MANAGEMENT SYSTEM, MODELS P1000, P2000. 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 July 23, 2010, 388 days after receiving the submission on June 30, 2009.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.1700.
| 510(k) Number | K091939 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 30, 2009 |
| Decision Date | July 23, 2010 |
| Days to Decision | 388 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 |