510(k) K191466 ยท GZB Stimulator, Spinal-Cord, Implanted (Pain Relief)
SandShark Injectable Anchor (SIA) System
| Applicant | Stimwave Technologies, Inc., Pompano Beach FL, US |
| Decision | Substantially Equivalent, Nov 7, 2019 |
| Received | Jun 3, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K191466
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.