Bolder Surgical, LLC
FDA 510(k) & PMA Approved Devices — 5 products
Total Devices5
Categories1
Latest FDA decision2023-11-15
| Type | Number | Device Name | Code | Date | Actions |
|---|---|---|---|---|---|
| 510(k) | K231012 | CoolSeal Trinity | GEI | 2023-11-15 | View |
| 510(k) | K211579 | CoolSeal Trinity (30 cm shaft), CoolSeal Trinity (37 cm shaft), CoolSeal Trinity (44 cm shaft) | GEI | 2021-09-07 | View |
| 510(k) | K203183 | CoolSeal Trinity (30 cm shaft, 37 cm shaft, and 44 cm shaft) | GEI | 2021-05-06 | View |
| 510(k) | K203640 | CoolSeal Reveal | GEI | 2021-05-06 | View |
| 510(k) | K202114 | CoolSeal Generator/CSL-200-50, CoolSeal Trinity (30 cm shaft)/CSL-TR105-30, CoolSeal Trinity (37 cm shaft)/CSL-TR105-37, CoolSeal Trinity (44 cm shaft)/CSL-TR105-44, CoolSeal Mini (20cm shaft)/CSL-MN103-20 | GEI | 2020-10-06 | View |
No matching devices.