510(k) K191280 ยท NAY System, Surgical, Computer Controlled Instrument
E-100 Electrosurgical Generator, SynchroSeal
| Applicant | Intuitive Surgical, Inc., Sunnyvale CA, US |
| Decision | Substantially Equivalent, Nov 14, 2019 |
| Received | May 13, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K191280
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 22, 2022 | Intuitive Surgical, Inc. The E-100 Generator (PN 374848-09) is a bipolar electrosurgical unit (ESU) designed to be used with the da Vinci Xi and X systems. The E-100 is installed on the Vision Cart and is connected to the sys Completed |
NAY | None listed |
| Mar 3, 2022 | Intuitive Surgical, Inc. DAVINCI | Energy SynchroSeal da Vinci X' da Vinci Xi', Single Use Instrument 8mm, REF 480440 Completed |
GEI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.