K200952 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 June 5, 2020, 57 days after receiving the submission on April 9, 2020.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.3880.
| 510(k) Number | K200952 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 09, 2020 |
| Decision Date | June 05, 2020 |
| Days to Decision | 57 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 |