THERMEDX FLUID MANAGMENT SYSTEM
FDA 510(k) clearance K133799 · decided 2014-06-20
Clearance details
- K-number
- K133799
- Device name
- THERMEDX FLUID MANAGMENT SYSTEM
- Applicant
- Thermedx, LLC
- Decision
- Substantially Equivalent
- Date received
- 2013-12-13
- Decision date
- 2014-06-20
- Days to decision
- 189 days
- Clearance type
- Traditional
- Product code
- HIG
- Device class
- 2
- Regulation number
- 884.1700
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Solon, OH, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Fluid Management System P4000; for irrigation and fluid warming in laparoscopic procedures recall (Z-1463-2015) | Thermedx LLC | 2015-04-20 |
| The Thermedx Fluid Management System is designed to provide irrigation fluids to irrigate, recall (Z-2555-2014) | Thermedx LLC | 2014-08-27 |