Xprecia Prime Coagulation System— 510(k) K230802

Name: FDA 510(k) clearance K230802
Creator: U.S. Food and Drug Administration
Published: 2024-03-15

Substantially Equivalent

Universal Biosensors Pty, Ltd.

FDA 510(k) clearance K230802 for Xprecia Prime Coagulation System, Substantially Equivalent on 2024-03-15. Applicant: Universal Biosensors Pty, Ltd.. Device class: 2.

Clearance details

Applicant: Universal Biosensors Pty, Ltd.
Product code: Code GJS
Device class: Class 2
Regulation: 21 CFR 864.7750
Advisory panel: Hematology
Date received: 2023-03-23
Decision date: 2024-03-15
Decision: Substantially Equivalent
Clearance type: Dual Track
Location: Rowville, AU

Download summary PDF View on FDA.gov ↗

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Adverse events under product code GJS

product code GJS

Death: 4
Injury: 229
Malfunction: 4,852
Total: 5,085

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.