K132721 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 (Laguna Beach, US). The FDA issued a Cleared decision on January 29, 2014, 152 days after receiving the submission on August 30, 2013.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.4780.
| 510(k) Number | K132721 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 30, 2013 |
| Decision Date | January 29, 2014 |
| Days to Decision | 152 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 |