510(k) K142024 ยท HAW Neurological Stereotaxic Instrument
BRIGHTMATTER NAVIGATION SYSTEM
| Applicant | Synaptive Medical, Inc., Toronto, CA |
| Decision | Substantially Equivalent, Apr 2, 2015 |
| Received | Jul 25, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K142024
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 23, 2015 | Synaptive Medical, Inc. Synaptive Medical BrightMatter Navigator System (Guide System). Part number SYN-0026. The Guide system is comprised of a cart labelled SYN-0024 and a cart labelled SYN-0025, Operator Cart. A planni Terminated |
HAW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.