510(k) Report

Devices descending from K111606

7 later devices reach Pinnacle Precision Access System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K252441Primero Safe Access SystemSouth53, LLC20250—
+1K152177SonoStik IV Guide Wire IntroducerSonostik, LLC20151—
+1K123475Shoocin Introducer KitLepu Medical Technology (Beijing) Co., Ltd.20143—
+2K243061SonoStik Guide Wire IntroducerSonostik, LLC20240—
+2K172099Shoocin Introducer KitLepu Medical Technology (Beijing) Co., Ltd.20170—
+2K140768Type I Brilliant Introducer Kit, Type II Brilliant Introducer Kit, Type Iii Brilliant…Lepu Medical Technology (Bejing) Co., Ltd.20141—
+3K172331Type I, Type II, Type III, Type IVLepu Medical Technology (Beijing) Co., Ltd.20180—