FLO-STAT FLUID MONITORING SYSTEM— 510(k) K954775

Substantially Equivalent

Gynecare Innovation Center

FDA 510(k) clearance K954775 for FLO-STAT FLUID MONITORING SYSTEM, Substantially Equivalent on 1996-05-10. Applicant: Gynecare Innovation Center.

Clearance details

Applicant: Gynecare Innovation Center
Product code: Code HET
Advisory panel: Obstetrics/Gynecology
Date received: 1995-10-17
Decision date: 1996-05-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sunnyvale, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code HET

product code HET

Malfunction: 10,504
Total: 10,504

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.