RETROX TITANIUM TUBE SYSTEM FOR THE RETROX TRANSCUTANEOUS AIR CONDUCTION HEARING AID SYSTEM
FDA 510(k) clearance K040996 · decided 2004-08-20
Clearance details
- K-number
- K040996
- Device name
- RETROX TITANIUM TUBE SYSTEM FOR THE RETROX TRANSCUTANEOUS AIR CONDUCTION HEARING AID SYSTEM
- Applicant
- Gyrus Ent LLC
- Decision
- Substantially Equivalent
- Date received
- 2004-04-16
- Decision date
- 2004-08-20
- Days to decision
- 126 days
- Clearance type
- Traditional
- Product code
- NIX
- Device class
- 2
- Regulation number
- 874.3950
- Medical specialty
- Ear, Nose, Throat
- Advisory committee
- Ear, Nose, Throat
- Location
- Bartlett, TN, 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 |
|---|---|---|
| RETROX (DEN020003) | Auric Hearing Systems, Inc. | 2002-08-20 |
Recalls involving this device
No recalls on record reference this clearance.