K221254 is an FDA 510(k) clearance for the Hummingbird Tympanostomy Tube System. This device is classified as a Tube, Tympanostomy (Class II - Special Controls, product code ETD).
Submitted by Preceptis Medical, Inc. (Maple Grove, US). The FDA issued a Cleared decision on July 27, 2022, 86 days after receiving the submission on May 2, 2022.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.3880.
| 510(k) Number | K221254 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 02, 2022 |
| Decision Date | July 27, 2022 |
| Days to Decision | 86 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 |