NEOZOLINE VENTILATION TUBES
FDA 510(k) clearance K061058 · decided 2006-07-12
Clearance details
- K-number
- K061058
- Device name
- NEOZOLINE VENTILATION TUBES
- Applicant
- Adept Medical, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2006-04-17
- Decision date
- 2006-07-12
- Days to decision
- 86 days
- Clearance type
- Traditional
- Product code
- ETD
- Device class
- 2
- Regulation number
- 874.3880
- Medical specialty
- Ear, Nose, Throat
- Advisory committee
- Ear, Nose, Throat
- Location
- Auckland, NZ
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Otological Ventilation Tube - T-Tube 6mm - Silicone; Product Code: NZ3306/NZ3306-2; recall (Z-0963-2025) | Adept Medical Ltd | 2025-01-17 |
| Otological Ventilation Tube - T-Tube 9mm - Double - Silicone; Product Code: NZ3309-2; recall (Z-0965-2025) | Adept Medical Ltd | 2025-01-17 |
| Otological Ventilation Tube - T-Tube 9mm - Silicone; Product Code: NZ3309; recall (Z-0966-2025) | Adept Medical Ltd | 2025-01-17 |
| Otological Ventilation Tube - T-Tube 12mm - Silicone; Product Code: NZ3312; recall (Z-0967-2025) | Adept Medical Ltd | 2025-01-17 |
| Otological Ventilation Tube - T-Tube 12mm - Double - Silicone; Product Code: NZ3312-2; recall (Z-0968-2025) | Adept Medical Ltd | 2025-01-17 |
| Otological Ventilation Tube - Donaldson - Blue Silicone; Product Code: NZ3321; recall (Z-0969-2025) | Adept Medical Ltd | 2025-01-17 |
| Otological Ventilation Tube - Donaldson - Double - Blue Silicone; Product Code: NZ3321-2; recall (Z-0970-2025) | Adept Medical Ltd | 2025-01-17 |