The following data is part of a premarket notification filed by Stimwave Technologies Incorporated with the FDA for Sandshark Injectable Anchor Kit, Injectroducer Handle, Loading Rod With Anchor, Loading Base.
| Device ID | K172644 |
| 510k Number | K172644 |
| Device Name: | Sandshark Injectable Anchor Kit, Injectroducer Handle, Loading Rod With Anchor, Loading Base |
| Classification | Stimulator, Spinal-cord, Implanted (pain Relief) |
| Applicant | Stimwave Technologies Incorporated 1310 Park Central Boulevard South Pompano Beach, FL 33064 |
| Contact | Elizabeth Greene |
| Correspondent | Elizabeth Greene Stimwave Technologies Incorporated 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 | 2017-09-01 |
| Decision Date | 2017-11-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00859619004202 | K172644 | 000 |
| 00850051034581 | K172644 | 000 |