Submission Details
| 510(k) Number | K151067 FDA.gov |
| FDA Decision | Cleared 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 |
Cleared
Traditional
Ventilation (Tympanostomy) Tubes
Jul 2015
Decision
92d
Days
Class 2
Risk
About This 510(k) Submission
K151067 is an FDA 510(k) clearance for the Ventilation (Tympanostomy) Tubes, 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 review panel. Regulated under 21 CFR 874.3880.
Device Classification
| Product Code | ETD — Tube, Tympanostomy |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 874.3880 |
Manufacturer
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