510(k) Report

Devices descending from K053262

2 later devices reach Ksea Unidrive Ent/Neuro/Omfs System and Accessories through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K150969Unidrive S III ENT 40701601-1 with KARL STORZ-SCB, DrillCut-X II Shaver Handpiece, High…Karl Storz Endoscopy America, Inc.20161—
+2K200318UNIDRIVE S II ENT, DrillCut-X II-35 Shaver Handpiece, DrillCut-X II-35 N Shaver HandpieceKARL STORZ Endoscopy-America, Inc.20200—