510(k) K092487 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
HALOFLEX ENERGY GENERATOR, MODELS 1190A-115A AND 1190A-230A
| Applicant | Barrx Medical, Incorporated, Sunnyvale CA, US |
| Decision | Substantially Equivalent, Nov 10, 2009 |
| Received | Aug 13, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K092487
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 14, 2012 | Covidien LLC HALO Flex Energy Generators
Manufactured by BRRX Medical (now Covidien)
540 Oakmead Parkway
Sunnyvale, CA 95085.
The HALO Flex Energy Generator is indicated for use for the coagulation of soft tissu Terminated |
GEI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.