510(k) K081766 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
PKS OMNI INSTRUMENT
| Applicant | Gyrus-Acmi L.P., Southborough MA, US |
| Decision | Substantially Equivalent, Aug 8, 2008 |
| Received | Jun 20, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K081766
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 9, 2021 | Olympus Corporation of the Americas Gyrus Acmi PKS Omni 5mm/33cm-intended for the electrosurgical coagulation, mechanical grasping, and dissection of tissue during the performance of laparoscopic and general open surgical procedures whe Terminated |
GEI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.