Clearance Summary
RITA RF GENERATOR AND ACCESSORIES, MODEL 500 SERIES received FDA 510(k) clearance under submission number K983214, sponsored by Rita Medical Systems. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2000-03-27.
- Submission: K983214
- Applicant / Sponsor: Rita Medical Systems
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.4400
- Decision date: 2000-03-27
Classification & Regulation
This clearance is catalogued under FDA product code GXD and 21 CFR 882.4400, within the Neurology review panel as a Class II device.