K181696 is an FDA 510(k) clearance for the ChitoZolve. This device is classified as a Splint, Intranasal Septal (Class I - General Controls, product code LYA).
Submitted by Gyrus Acmi, Inc. (Southborough, US). The FDA issued a Cleared decision on November 30, 2018, 156 days after receiving the submission on June 27, 2018.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.4780.
| 510(k) Number | K181696 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 27, 2018 |
| Decision Date | November 30, 2018 |
| Days to Decision | 156 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 |