| Device Type ID | 1471 |
| Device Name | Prosthesis, Laryngeal (taub) |
| Regulation Description | Laryngeal Prosthesis (Taub Design). |
| 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 | 874.3730 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | EWL |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Expansion Pilot Program |
| Device Type ID | 1471 |
| Device | Prosthesis, Laryngeal (taub) |
| Product Code | EWL |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Laryngeal Prosthesis (Taub Design). |
| CFR Regulation Number | 874.3730 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
ATOS MEDICAL AB | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Device Dislodged Or Dislocated | 15 |
Improper Or Incorrect Procedure Or Method | 9 |
Insufficient Information | 8 |
Leak / Splash | 3 |
Mechanical Jam | 2 |
Inadequacy Of Device Shape And/or Size | 1 |
Missing Value Reason | 1 |
Fluid Leak | 1 |
Device Or Device Fragments Location Unknown | 1 |
Adverse Event Without Identified Device Or Use Problem | 1 |
| Total Device Problems | 42 |