Bolder Surgical, LLC - FDA 510(k) Cleared Devices
Recent clearances: CoolSeal Trinity, CoolSeal Trinity (30 cm shaft), CoolSeal Trinity (37 cm shaft), CoolSeal Trinity (44 cm shaft), CoolSeal Trinity (30 cm shaft, 37 cm shaft, and 44 cm shaft)
5
Total
5
Cleared
0
Denied
FDA 510(k) Regulatory Record - Bolder Surgical, LLC General & Plastic Surgery ✕
5 devices
Cleared
Nov 15, 2023
CoolSeal Trinity
General & Plastic Surgery
219d
Cleared
Sep 07, 2021
CoolSeal Trinity (30 cm shaft), CoolSeal Trinity (37 cm shaft), CoolSeal...
General & Plastic Surgery
109d
Cleared
May 06, 2021
CoolSeal Trinity (30 cm shaft, 37 cm shaft, and 44 cm shaft)
General & Plastic Surgery
191d
Cleared
May 06, 2021
CoolSeal Reveal
General & Plastic Surgery
143d
Cleared
Oct 06, 2020
CoolSeal Generator/CSL-200-50, CoolSeal Trinity (30 cm shaft)/CSL-TR105-30,...
General & Plastic Surgery
68d