510(k) K073207 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
OLYMPUS ESG-100, MODEL WB991046; OLYMPUS AFU-100, MODEL WB950167
| Applicant | Celon AG Medical Instruments, Center Valley PA, US |
| Decision | Substantially Equivalent, May 8, 2008 |
| Received | Nov 13, 2007 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K073207
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 13, 2012 | Olympus America Inc. Olympus Electrosurgical Unit.
The Olympus Electrosurgical Unit (ESG-100) is used in conjunction with cutting and coagulation electrosurgical devices intended for use in electrosurgery procedures duri Terminated |
GEI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.