510(k) Report

Devices descending from K060947

11 later devices reach Sonicath Ultra Imaging Catheter, 3.2F,20MHZ Models 37410/456221/C1020 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K092156Cad 12, Colonoscopy Assist DeviceSoftscope Medical Technologies, Inc.20097—
+1K073623Atlantis 018 Peripheral Imaging CatheterBoston Scientific Corp20082—
+2K160514OptiCross 18, 30 MHz Peripheral Imaging CatheterBoston Scientific Corporation20161—
+2K100624Invendo C20 Colonoscopy SystemInvendo Medical Gbmh20126—
+3K222568OptiCross™ 18 Peripheral Imaging CatheterBoston Scientific Corporation20220—
+3K161355invendoscopy E200 SystemInvendo Medical GmbH20161—
+3K161791Aer-O-Scope Colonoscope SystemGi View, Ltd.20160—
+3K141286Aer-O-Scope Colonoscope SystemGi View, Ltd.20142—
+3K121582Invendo C25 Colonoscopy SystemInvendo Medical Gbmh20125—
+4K190669EndoticsEra Endoscopy S.R.L.20200—
+4K173085invendoscopy E210 SystemInvendo Medical GmbH20180—