TUTA HEALTHCARE ARTHROSCOPY FLUSHING SET, MODEL 80.601— 510(k) K020083

Substantially Equivalent

Tuta Healthcare Pty Limited

FDA 510(k) clearance K020083 for TUTA HEALTHCARE ARTHROSCOPY FLUSHING SET, MODEL 80.601, Substantially Equivalent on 2002-02-12. Applicant: Tuta Healthcare Pty Limited.

Clearance details

Applicant: Tuta Healthcare Pty Limited
Product code: Code HRX
Advisory panel: Orthopedic
Date received: 2002-01-10
Decision date: 2002-02-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sydney Nsw, AU

Download summary PDF View on FDA.gov ↗

Adverse events under product code HRX

product code HRX

Injury: 623
Malfunction: 11,257
Total: 11,880

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.