510(k) K143517 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
Voyant Open Sealer-Divider Device
| Applicant | Applied Medical Resources, Rancho Santa CA, US |
| Decision | Substantially Equivalent, Mar 27, 2015 |
| Received | Dec 12, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K143517
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 15, 2015 | Applied Medical Resources Corp Voyant Open Fusion Device
Models: EB040 and EB040+
Product Usage: The Applied Voyant Open Fusion Device is designed for use with the Voyant Electrosurgical Generator. The device is an advanced bipol Terminated |
GEI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.