FDA applicant
Rita Medical Systems
FDA records 20 decisions for Rita Medical Systems (Mountain View, CA) from 1998 to 2007: 20 510(k) clearances. Most are in product codes GEI (Electrosurgical, Cutting & Coagulation &…) and LJT (Port & Catheter, Implanted, Subcutaneous…). Its devices cite 23 predicates, 6 of them its own earlier devices. 11 recalls are linked to its devices.
FDA’s records also spell it “Rita Medical Systems, Inc.”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Rita Medical Systems’s devices, and how often a recall has named them.
FDA decisions per year
2in 2007
2026 so far, outlined.
Recalls per year
1in 2021
Class I Class II/III not classified
Planning a device like Rita Medical Systems’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) Report