C-FLEX ENDOLYMPHATIC SHUNT
Device Facts
| Record ID | K952227 |
|---|---|
| Device Name | C-FLEX ENDOLYMPHATIC SHUNT |
| Applicant | Trebay Medical Corp. |
| Product Code | ESZ · Ear, Nose, Throat |
| Decision Date | Jun 16, 1995 |
| 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.
