510(k) K153281 ยท HAW Neurological Stereotaxic Instrument
BrightMatter Guide with Surface Trace Registration
| Applicant | Synaptive Medical, Inc., Toronto, CA |
| Decision | Substantially Equivalent, Mar 30, 2016 |
| Received | Nov 12, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K153281
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 26, 2018 | Synaptive Medical Inc BrightMatter Guide, Product Number SYN-0026, Versions: 1.5.0, 1.5.1 and 1.5.2
Product Usage:
BrightMatter Guide can navigate a third-party port (NICO BrainPath device) by attaching Synaptive s custom Terminated |
HAW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.