K151067 is an FDA 510(k) clearance for the Ventilation (Tympanostomy) Tubes. This device is classified as a Tube, Tympanostomy (Class II - Special Controls, product code ETD).
Submitted by Medtronic Xomed, Inc. (Jacksonville, US). The FDA issued a Cleared decision on July 22, 2015, 92 days after receiving the submission on April 21, 2015.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.3880.
| 510(k) Number | K151067 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 21, 2015 |
| Decision Date | July 22, 2015 |
| Days to Decision | 92 days |
| Submission Type | Traditional |
| Review Panel | Ear, Nose, Throat (EN) |
| Summary | Summary PDF |
| Product Code | ETD — Tube, Tympanostomy |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 874.3880 |