AUSTIN ENDOLYMPH DISPERSMENT SHUNT
FDA 510(k) clearance K834094 · decided 1984-09-20
Clearance details
- K-number
- K834094
- Device name
- AUSTIN ENDOLYMPH DISPERSMENT SHUNT
- Applicant
- Treace Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1983-11-28
- Decision date
- 1984-09-20
- Days to decision
- 297 days
- Clearance type
- Traditional
- Product code
- ESZ
- Device class
- 2
- Regulation number
- 874.3820
- Medical specialty
- Ear, Nose, Throat
- Advisory committee
- Ear, Nose, Throat
- Location
- Walker, MI, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| ENDOLYMPHATIC SAC TO MASTOID T-SHUNT (K974224) | Exmoor Plastics , Ltd. | 1998-01-27 |
| C-FLEX ENDOLYMPHATIC SHUNT (K952227) | Trebay Medical Corp. | 1995-06-16 |
| GIBSON ENDOLYMPHATIC SHUNT (K897049) | Hood Laboratories | 1990-03-16 |
Recalls involving this device
No recalls on record reference this clearance.