Tube, Shunt, Endolymphatic
The endolymphatic shunt tube is an implantable device surgically placed to drain excess endolymphatic fluid from the inner ear, intended as a treatment for Meniere's disease and associated endolymphatic hydrops. It is classified as FDA Class 2, requiring 510(k) premarket clearance. The product code is ESZ, regulated under 21 CFR 874.3820 in the Ear, Nose, Throat specialty. This device is designated as an implant.
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Basic Information
- Product Code
- ESZ
- Device Class
- FDA class 2
- Regulation Number
- 874.3820
- Medical Specialty
- Ear, Nose, Throat
- Review Panel
- EN
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 4 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K974224 | ENDOLYMPHATIC SAC TO MASTOID T-SHUNT | Jan 27, 1998 | Substantially Equivalent | Exmoor Plastics , Ltd. |
| K952227 | C-FLEX ENDOLYMPHATIC SHUNT | Jun 16, 1995 | Substantially Equivalent | Trebay Medical Corp. |
| K897049 | GIBSON ENDOLYMPHATIC SHUNT | Mar 16, 1990 | Substantially Equivalent | Hood Laboratories |
| K834094 | AUSTIN ENDOLYMPH DISPERSMENT SHUNT | Sep 20, 1984 | Substantially Equivalent | Treace Medical, Inc. |
FEI Numbers
This FDA classification entry is associated with 3 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 3 registration numbers. Click on an entry to view related FDA registrations.