510(k) K133799 ยท HIG Insufflator, Hysteroscopic
THERMEDX FLUID MANAGMENT SYSTEM
| Applicant | Thermedx, LLC, Solon OH, US |
| Decision | Substantially Equivalent, Jun 20, 2014 |
| Received | Dec 13, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K133799
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 20, 2015 | Thermedx LLC Fluid Management System P4000; for irrigation and fluid warming in laparoscopic procedures, and distention, fluid warming, and volume/deficit measurements in endoscopic procedures within gynecology, Terminated |
HIG | None listed |
| Aug 27, 2014 | Thermedx LLC The Thermedx Fluid Management System is designed to provide irrigation fluids to irrigate, distend, and debride while warming the fluid to assist in the prevention of peri-operative hypothermia. The f Terminated |
OJR | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.