| Device Type ID | 1611 |
| Device Name | System, Vocal Cord Medialization |
| Regulation Description | Ear, Nose, And Throat Synthetic Polymer Material. |
| 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 | 874.3620 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | MIX |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 1611 |
| Device | System, Vocal Cord Medialization |
| Product Code | MIX |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Ear, Nose, And Throat Synthetic Polymer Material. |
| CFR Regulation Number | 874.3620 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
CYTOPHIL, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Insufficient Information | 3 |
Adverse Event Without Identified Device Or Use Problem | 3 |
Difficult Or Delayed Positioning | 1 |
Short Fill | 1 |
Leak / Splash | 1 |
| Total Device Problems | 9 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Merz North America, Inc. | II | Dec-03-2015 |