510(k) Report

Devices descending from K202114

4 later devices reach CoolSeal Generator/CSL-200-50, CoolSeal Trinity (30 cm shaft)/CSL-TR105-30… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K253634CoolSeal Generator® (CSL-200-90)Hologic, Inc.20260—
+1K203183CoolSeal Trinity (30 cm shaft, 37 cm shaft, and 44 cm shaft)Bolder Surgical, LLC20212—
+2K211579CoolSeal Trinity (30 cm shaft), CoolSeal Trinity (37 cm shaft), CoolSeal Trinity (44 cm…Bolder Surgical, LLC20211—
+3K231012CoolSeal TrinityBolder Surgical, LLC20230—