510(k) K192265 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
gi-4000 Electrosurgical Generator
| Applicant | United States Endoscopy Group, Inc., Mentor OH, US |
| Decision | Substantially Equivalent, May 21, 2020 |
| Received | Aug 21, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K192265
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 16, 2022 | Steris Corporation GI4000 Electrosurgical Unit - intended to deliver electrosurgical outputs to perform cutting and/or coagulation and coagulation with or without delivery of argon gas, in flexible endoscopic applicatio Terminated |
GEI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.