K140992 is an FDA 510(k) clearance for the ARTHROCARE NASASTENT CMC NASAL DRESSING. This device is classified as a Splint, Intranasal Septal (Class I - General Controls, product code LYA).
Submitted by ArthroCare Corporation (Austin, US). The FDA issued a Cleared decision on June 16, 2014, 60 days after receiving the submission on April 17, 2014.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.4780.
| 510(k) Number | K140992 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 17, 2014 |
| Decision Date | June 16, 2014 |
| Days to Decision | 60 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 |