EWL
- Product code
- EWL
- Device name
- Prosthesis, Laryngeal (Taub)
- Device class
- Class 2
- 21 CFR
- 21 CFR 874.3730
- Medical specialty
- Ear, Nose, Throat
- Marketing pathway
- 510(K)
- 510(k) clearances (last 3 years)
- 40
510(k) clearances, last 3 years (1)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K240763 | 2024-12-18 | Freudenberg Medical, LLC | FirstFit Surgical Kit |
Official FDA classification page: EWL
Classification and pathway per current FDA publications. Data from openFDA (CC0).