K232702 is an FDA 510(k) clearance for the Solo+ Tympanostomy Tube Device (TTD). This device is classified as a Tube, Tympanostomy (Class II - Special Controls, product code ETD).
Submitted by Aventamed Dac (Bishopstown, IE). The FDA issued a Cleared decision on May 20, 2024, 258 days after receiving the submission on September 5, 2023.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.3880.
| 510(k) Number | K232702 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 05, 2023 |
| Decision Date | May 20, 2024 |
| Days to Decision | 258 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 |