510(k) K984552 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
COOL-TIP RF SYSTEM
| Applicant | Radionics, Inc., Burlington MA, US |
| Decision | Substantially Equivalent, Mar 5, 1999 |
| Received | Dec 22, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K984552
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 10, 2006 | Covidien LP Cool-tip RF Generator, for use in percutaneous, laparoscopic, intraoperative coagulation and ablation of tissue. Terminated |
GEI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.