THERMEDX PRODIGY FLUID MANAGEMENT SYSTEM, MODELS P1000, P2000— 510(k) K091939
Substantially EquivalentThermedx, LLC
FDA 510(k) clearance K091939 for THERMEDX PRODIGY FLUID MANAGEMENT SYSTEM, MODELS P1000, P2000, Substantially Equivalent on 2010-07-23. Applicant: Thermedx, LLC. Device class: 2.
Clearance details
- Applicant
- Thermedx, LLC
- Product code
- Code HIG
- Device class
- Class 2
- Regulation
- 21 CFR 884.1700
- Advisory panel
- Obstetrics/Gynecology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Solon, OH, US
Recent devices under product code HIG
view allMore clearances from Thermedx, LLC
view allAdverse events under product code HIG
product code HIG- Death
- 8
- Other
- 2
- Total
- 10
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K091939
K-number listed on FDA's recall record- Z-1463-2015 — 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, urology, and orthopedic procedures.
- Z-2555-2014 — 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 fluid is warmed via an internal infrared mechanism. Additionally the system will hold suction canisters for the collection of used irrigant.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K091939.
Data sourced from openFDA. This site is unofficial and independent of the FDA.