THERMEDX PRODIGY FLUID MANAGEMENT SYSTEM, MODELS P1000, P2000— 510(k) K091939

Substantially Equivalent

Thermedx, LLC

FDA 510(k) clearance K091939 for THERMEDX PRODIGY FLUID MANAGEMENT SYSTEM, MODELS P1000, P2000, Substantially Equivalent on 2010-07-23. Applicant: Thermedx, LLC.

Clearance details

Applicant: Thermedx, LLC
Product code: Code HIG
Advisory panel: Obstetrics/Gynecology
Date received: 2009-06-30
Decision date: 2010-07-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Solon, OH, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code HIG

product code HIG

Death: 8
Other: 2
Total: 10

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.