| Device Type ID | 1457 |
| Device Name | Tube, Tympanostomy |
| Regulation Description | Tympanostomy Tube. |
| Regulation Medical Specialty | Ear Nose & Throat |
| Review Panel | Ear Nose & Throat |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Ophthalmic And Ear, Nose And Throat Devices (DOED) Ear, Nose, And Throat Devices Branch (ENTB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 874.3880 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | ETD |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 1457 |
| Device | Tube, Tympanostomy |
| Product Code | ETD |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Tympanostomy Tube. |
| CFR Regulation Number | 874.3880 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
MEDTRONIC INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MEDTRONIC, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
PRECEPTIS MEDICAL | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
| Device Problems | |
|---|---|
Adverse Event Without Identified Device Or Use Problem | 9 |
Device Packaging Compromised | 1 |
| Total Device Problems | 10 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Summit Medical, Inc. | II | Jun-09-2014 |