The following data is part of a premarket notification filed by Stimwave Technologies Inc. with the FDA for Sandshark Injectable Anchor (sia) System.
| Device ID | K191466 |
| 510k Number | K191466 |
| Device Name: | SandShark Injectable Anchor (SIA) System |
| Classification | Stimulator, Spinal-cord, Implanted (pain Relief) |
| Applicant | Stimwave Technologies Inc. 1310 Park Central Boulevard South Pompano Beach, FL 33064 |
| Contact | Elizabeth Greene |
| Correspondent | Elizabeth Greene Stimwave Technologies Inc. 1310 Park Central Boulevard South Pompano Beach, FL 33064 |
| Product Code | GZB |
| CFR Regulation Number | 882.5880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-06-03 |
| Decision Date | 2019-11-07 |