510(k) K010060 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
RITA STARBURST XLI ELECTROSURGICAL DEVICE
| Applicant | Rita Medical Systems, Mountain View CA, US |
| Decision | Substantially Equivalent, Jan 23, 2001 |
| Received | Jan 8, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K010060
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 2, 2019 | Angiodynamics Inc. (Navilyst Medical Inc.) Starburst Talon Semi-Flex Electrosurgical Device, Part Number H7877001028451 incorrectly labelled as Starburst MRI Semi-Flex Electrosurgical Device, Part Number H7877001026151 Terminated |
GEI | None listed |
| May 31, 2006 | Rita Medical Systems, Inc. Talon Straight, 25 cm--Electrosurgical Device--RITA * Medical Systems, Inc. * StarBurst Talon * * REF: 700-102846 * 4 cm Diameter * 25 cm Length * Sterile/R * Catalog # 700-102846-RITA * Manufactured Terminated |
GEI | None listed |
| May 31, 2006 | Rita Medical Systems, Inc. XLie with Tubing, 12 cm, Electrosurgical Device-RITA * Medical Systems, Inc. * StarBurst Xli enhanced with tubing set * * REF/Catalog: 700-103027 * 4-7 cm Diameter * 12cm Length * Sterile/R * RITA * Terminated |
GEI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.