Clearance Summary
ADI 9000/9001 ARTHROSCOPE AND ACCESSORIES received FDA 510(k) clearance under submission number K992621, sponsored by Advanced Diagnostics & Interventions. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 1999-11-08.
- Submission: K992621
- Applicant / Sponsor: Advanced Diagnostics & Interventions
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.1100
- Decision date: 1999-11-08
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.