510(k) Report

Devices descending from K991625

7 later devices reach Komet XK-95 Perforator Motor (MI-102) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K042974Medicon Vipair High Speed SystemMedicon EG20050—
+1K013091ZMM 2000 Zeppelin Millennium Motordrill SystemVon Zeppelin GmbH20026—
+2K130755Hicut Highspeed InstrumentAdeor Medical AG20144—
+3K232684Surgify HaloSurgify Medical OY20233—
+4K250380Surgify Halo (54.085.SHD.H1); Surgify Halo (54.140.SHD.H1); Surgify Halo…Surgify Medical OY202525
+5K251433Surgify Halo (54.085.SHD.H1); Surgify Halo (54.140.SHD.H1); Surgify Halo…Surgify Medical OY202513
+6K253627Surgify Halo (54.085.SHD.U1); Surgify Halo (54.140.SHD. U1); Surgify Halo…Surgify Medical OY2026011