510(k) Report

Devices descending from K203183

2 later devices reach CoolSeal Trinity (30 cm shaft, 37 cm shaft, and 44 cm shaft) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K211579CoolSeal Trinity (30 cm shaft), CoolSeal Trinity (37 cm shaft), CoolSeal Trinity (44 cm…Bolder Surgical, LLC20211—
+2K231012CoolSeal TrinityBolder Surgical, LLC20230—