Bolder Surgical, LLC
FDA Regulatory Profile
Bolder Surgical, LLC appears in FDA public data with 1 recall, 5 510(k) clearances, 3 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-0736-2022, Class II) was initiated on January 25, 2022. Its most recent 510(k) clearance was granted on November 15, 2023.
Summary
- Total Recalls
- 1
- 510(k) Clearances
- 5
- Inspections
- 3
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0736-2022 | Class II | CoolSeal Generator, REF: CSL-200-50 | January 25, 2022 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K231012 | CoolSeal Trinity | November 15, 2023 |
| K211579 | CoolSeal Trinity (30 cm shaft), CoolSeal Trinity (37 cm shaft), CoolSeal Trinity (44 cm shaft) | September 7, 2021 |
| K203640 | CoolSeal Reveal | May 6, 2021 |
| K203183 | CoolSeal Trinity (30 cm shaft, 37 cm shaft, and 44 cm shaft) | May 6, 2021 |
| K202114 | CoolSeal Generator/CSL-200-50, CoolSeal Trinity (30 cm shaft)/CSL-TR105-30, CoolSeal Trinity (37 cm | October 6, 2020 |