Clearance Summary
TUTA HEALTHCARE ARTHROSCOPY FLUSHING SET, MODEL 80.601 received FDA 510(k) clearance under submission number K020083, sponsored by Tuta Healthcare Pty Limited. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2002-02-12.
- Submission: K020083
- Applicant / Sponsor: Tuta Healthcare Pty Limited
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.1100
- Decision date: 2002-02-12
Classification & Regulation
This clearance is catalogued under FDA product code HRX and 21 CFR 888.1100, within the Orthopedic review panel as a Class II device.