K202623 is an FDA 510(k) clearance for the Novapak Nasal Sinus Packing and Stent. This device is classified as a Splint, Intranasal Septal (Class I - General Controls, product code LYA).
Submitted by Medtronic Xomed (Jacksonville, US). The FDA issued a Cleared decision on December 8, 2020, 89 days after receiving the submission on September 10, 2020.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.4780.
| 510(k) Number | K202623 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 10, 2020 |
| Decision Date | December 08, 2020 |
| Days to Decision | 89 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 |