K233658 is an FDA 510(k) clearance for the Biowy Tym Tube (TT). This device is classified as a Tube, Tympanostomy (Class II - Special Controls, product code ETD).
Submitted by Biowy Corporation (Lake Forest, US). The FDA issued a Cleared decision on February 16, 2024, 93 days after receiving the submission on November 15, 2023.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.3880.
| 510(k) Number | K233658 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 15, 2023 |
| Decision Date | February 16, 2024 |
| Days to Decision | 93 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 |