K082188 is an FDA 510(k) clearance for the TYMPANOSTOMY TUBE. 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 September 19, 2008, 46 days after receiving the submission on August 4, 2008.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.3880.
| 510(k) Number | K082188 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 04, 2008 |
| Decision Date | September 19, 2008 |
| Days to Decision | 46 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 |