ESZ — Tube, Shunt, Endolymphatic Class II
FDA product code ESZ covers "Tube, Shunt, Endolymphatic", a Class II medical device regulated under 21 CFR 874.3820. Submissions are reviewed by the Ear, Nose, Throat panel. Devices under this code are implants. At least 4 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- ESZ
- Device Class
- Class II
- Regulation Number
- 874.3820
- Submission Type
- Review Panel
- EN
- Medical Specialty
- Ear, Nose, Throat
- Implant
- Yes
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K974224 | exmoor plastics | ENDOLYMPHATIC SAC TO MASTOID T-SHUNT | January 27, 1998 |
| K952227 | trebay medical | C-FLEX ENDOLYMPHATIC SHUNT | June 16, 1995 |
| K897049 | hood laboratories | GIBSON ENDOLYMPHATIC SHUNT | March 16, 1990 |
| K834094 | treace medical | AUSTIN ENDOLYMPH DISPERSMENT SHUNT | September 20, 1984 |