510(k) Report

Devices descending from K992351

3 later devices reach Sealouette Fibrin Sealant Applicator through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K020666Duploject Easy-Prep System 1ML, 2ML, 5MLBaxter Healthcare Corp200211
+1K014088DuploreachBaxter Healthcare Corp20021—
+2K071126Cryoseal FS Applicator SystemThermogenesis Corp.20070—