FluidSmart— 510(k) K172048

Substantially Equivalent

Thermedx, LLC

FDA 510(k) clearance K172048 for FluidSmart, Substantially Equivalent on 2017-09-05. Applicant: Thermedx, LLC.

Clearance details

Applicant: Thermedx, LLC
Product code: Code HIG
Advisory panel: Obstetrics/Gynecology
Date received: 2017-07-06
Decision date: 2017-09-05
Decision: Substantially Equivalent
Clearance type: Special
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.