K213153 is an FDA 510(k) clearance for the SPIWay Endonasal Access Guide. This device is classified as a Splint, Intranasal Septal (Class I - General Controls, product code LYA).
Submitted by Spiway, LLC (Carlsbad, US). The FDA issued a Cleared decision on October 27, 2021, 29 days after receiving the submission on September 28, 2021.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.4780.
| 510(k) Number | K213153 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 28, 2021 |
| Decision Date | October 27, 2021 |
| Days to Decision | 29 days |
| Submission Type | Special |
| Review Panel | Ear, Nose, Throat (EN) |
| Summary | Summary PDF |
| Product Code | LYA - Splint, Intranasal Septal |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 874.4780 |