BURETTE-IN LINE (150 ML)— 510(k) K023595

Substantially Equivalent

Tuta Healthcare Pty Limited

FDA 510(k) clearance K023595 for BURETTE-IN LINE (150 ML), Substantially Equivalent on 2002-12-18. Applicant: Tuta Healthcare Pty Limited.

Clearance details

Applicant: Tuta Healthcare Pty Limited
Product code: Code FPA
Advisory panel: General Hospital
Date received: 2002-10-28
Decision date: 2002-12-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sydney Nsw, AU

Download summary PDF View on FDA.gov ↗

Adverse events under product code FPA

product code FPA

Death: 95
Injury: 14,421
Malfunction: 125,815
Other: 30
Total: 140,361

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.