K153686 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 (San Clemente, US). The FDA issued a Cleared decision on January 28, 2016, 36 days after receiving the submission on December 23, 2015.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.4780.
| 510(k) Number | K153686 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 23, 2015 |
| Decision Date | January 28, 2016 |
| Days to Decision | 36 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 |