K152121 is an FDA 510(k) clearance for the NuVent EM Sinus Dilation System. This device is classified as a Instrument, Ent Manual Surgical (Class I - General Controls, product code LRC).
Submitted by Medtronic Xomed, Inc. (Jacksonville, US). The FDA issued a Cleared decision on December 1, 2015, 124 days after receiving the submission on July 30, 2015.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.4420.
| 510(k) Number | K152121 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 30, 2015 |
| Decision Date | December 01, 2015 |
| Days to Decision | 124 days |
| Submission Type | Traditional |
| Review Panel | Ear, Nose, Throat (EN) |
| Summary | Summary PDF |
| Product Code | LRC — Instrument, Ent Manual Surgical |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 874.4420 |