The following data is part of a premarket notification filed by Spiway, Llc with the FDA for Spiway Endonasal Access Guide.
| Device ID | K213153 |
| 510k Number | K213153 |
| Device Name: | SPIWay Endonasal Access Guide |
| Classification | Splint, Intranasal Septal |
| Applicant | SPIWay, LLC 3600 Corte Castillo Carlsbad, CA 92009 |
| Contact | Eugene Chen |
| Correspondent | Mary Lou Mooney SPIWay, LLC 3600 Corte Castillo Carlsbad, CA 92009 |
| Product Code | LYA |
| CFR Regulation Number | 874.4780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-09-28 |
| Decision Date | 2021-10-27 |