Turbett Surgical Container
FDA 510(k) clearance K153025 · decided 2016-01-14
Clearance details
- K-number
- K153025
- Device name
- Turbett Surgical Container
- Applicant
- Turbett Surgical, LLC
- Decision
- Substantially Equivalent
- Date received
- 2015-10-16
- Decision date
- 2016-01-14
- Days to decision
- 90 days
- Clearance type
- Traditional
- Product code
- FRG
- Device class
- 2
- Regulation number
- 880.6850
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Rochester, NY, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Turbett Surgical Container, TS1200: Indicated for enclosing other medical devices that are recall (Z-1037-2023) | Turbett Surgical, Inc. | 2023-01-30 |
| Turbett Surgical Container, TS1000: Indicated for enclosing other medical devices that are recall (Z-1038-2023) | Turbett Surgical, Inc. | 2023-01-30 |
| Turbett Surgical Container, TS1500 recall (Z-1501-2022) | Turbett Surgical, Inc. | 2022-08-04 |
| Turbett Surgical Container, TS1500 recall (Z-1111-2022) | TURBETT SURGICAL, LLC | 2022-05-18 |