TURBETT SURGICAL, LLC
FDA Regulatory Profile
TURBETT SURGICAL, LLC appears in FDA public data with 4 recalls, 4 510(k) clearances, 4 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-1037-2023, Class II) was initiated on December 5, 2022. Its most recent 510(k) clearance was granted on April 4, 2025.
Summary
- Total Recalls
- 4
- 510(k) Clearances
- 4
- Inspections
- 4
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1037-2023 | Class II | Turbett Surgical Container, TS1200: Indicated for enclosing other medical devices that are to be ste | December 5, 2022 |
| Z-1038-2023 | Class II | Turbett Surgical Container, TS1000: Indicated for enclosing other medical devices that are to be ste | December 5, 2022 |
| Z-1501-2022 | Class II | Turbett Surgical Container, TS1500 | April 14, 2022 |
| Z-1111-2022 | Class II | Turbett Surgical Container, TS1500 | April 1, 2022 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K250011 | Turbett Surgical Instrument Pod (TS1500); Turbett Surgical Instrument Pod (TS1200); Turbett Surgical | April 4, 2025 |
| K202593 | Turbett Instrument Pod | May 19, 2021 |
| K200240 | Turbett Instrument Pod | April 30, 2020 |
| K153025 | Turbett Surgical Container | January 14, 2016 |