ESZ · Tube, Shunt, Endolymphatic
Ear, Nose, Throat · 21 CFR 874.3820 · Class 2
Overview
| Product Code | ESZ |
|---|---|
| Device Name | Tube, Shunt, Endolymphatic |
| Regulation | 21 CFR 874.3820 |
| Device Class | Class 2 |
| Review Panel | Ear, Nose, Throat |
| Implant | Yes |
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.
Classification Rationale
Class II.
Recent Cleared Devices (4 of 4)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K974224 | ENDOLYMPHATIC SAC TO MASTOID T-SHUNT | Exmoor Plastics , Ltd. | Jan 27, 1998 | SESE |
| K952227 | C-FLEX ENDOLYMPHATIC SHUNT | Trebay Medical Corp. | Jun 16, 1995 | SESE |
| K897049 | GIBSON ENDOLYMPHATIC SHUNT | Hood Laboratories | Mar 16, 1990 | SESE |
| K834094 | AUSTIN ENDOLYMPH DISPERSMENT SHUNT | Treace Medical, Inc. | Sep 20, 1984 | SESE |
Top Applicants
- Exmoor Plastics , Ltd. — 1 clearance
- Hood Laboratories — 1 clearance
- Treace Medical, Inc. — 1 clearance
- Trebay Medical Corp. — 1 clearance
