AUSTIN ENDOLYMPH DISPERSMENT SHUNT
Device Facts
| Record ID | K834094 |
|---|---|
| Device Name | AUSTIN ENDOLYMPH DISPERSMENT SHUNT |
| Applicant | Treace Medical, Inc. |
| Product Code | ESZ · Ear, Nose, Throat |
| Decision Date | Sep 20, 1984 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 874.3820 |
| Device Class | Class 2 |
Regulatory Classification
Identification
An endolymphatic shunt is a device that consists of a tube or sheet intended to be implanted to relieve the symptons of vertigo. The device permits the unrestricted flow of excess endolymph from the distended end of the endolymphatic system into the mastoid cavity where resorption occurs. This device is made of polytetrafluoroethylene or silicone elastomer.
