Clearance Summary
MR COMPATIBLE RITA MODEL 90 ELECTOSURGICAL ACCESSORY received FDA 510(k) clearance under submission number K023846, sponsored by Rita Medical Systems. The device was reviewed via the Special premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 2002-12-06.
- Submission: K023846
- Applicant / Sponsor: Rita Medical Systems
- Clearance pathway: Special
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4400
- Decision date: 2002-12-06
Classification & Regulation
This clearance is catalogued under FDA product code GEI and 21 CFR 878.4400, within the General, Plastic Surgery review panel as a Class II device.