K243655 is an FDA 510(k) clearance for the TurbAlign. This device is classified as a Splint, Intranasal Septal (Class I - General Controls, product code LYA).
Submitted by Spirair, Inc. (South San Francisco, US). The FDA issued a Cleared decision on July 11, 2025, 227 days after receiving the submission on November 26, 2024.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.4780.
| 510(k) Number | K243655 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 26, 2024 |
| Decision Date | July 11, 2025 |
| Days to Decision | 227 days |
| Submission Type | Traditional |
| 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 |