K250256 is an FDA 510(k) clearance for the Solo+ Tympanostomy Tube Device (TTD), Solo+ TTD, Solo+ (Solo+ Tympanostomy Tube Handpiece (Catalogue #: 12115-100-000) and Solo+ Tympanostomy Tube Cartridge (Catalogue #: 12115-200-000)). 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 April 28, 2025, 90 days after receiving the submission on January 28, 2025.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.3880.
| 510(k) Number | K250256 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 28, 2025 |
| Decision Date | April 28, 2025 |
| Days to Decision | 90 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 |