K103595 is an FDA 510(k) clearance for the ACCLARENT TYMPANOSTOMY TUBE AND TYMPANOSTOMY TUBE DELIVERY SYSTEM. This device is classified as a Tube, Tympanostomy (Class II - Special Controls, product code ETD).
Submitted by Acclarent, Inc. (Rmenlo Park, US). The FDA issued a Cleared decision on April 1, 2011, 114 days after receiving the submission on December 8, 2010.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.3880.
| 510(k) Number | K103595 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 08, 2010 |
| Decision Date | April 01, 2011 |
| Days to Decision | 114 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 |