510(k) Report

Devices descending from K963252

19 later devices reach TBAN through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K090853Yield Tissue SamplerBroncus Technologies, Inc.20090—
+1K040018Excelon Transbronchial Aspiration Needle, Models 6410, 6411, 6412Boston Scientific Corp200417—
+1K024165Dual-Lumen CatheterBistech, Inc.20030—
+2K142839GenCut Core Biopsy SystemCovidien, LLC201515—
+3K163537Arcpoint pulmonary needle - 18 ga, Arcpoint pulmonary needle - 21 gaCovidien, LLC201714—
+4K221340iNod Ultrasound Guided Biopsy Needle (UPN: M00502060), iNod Ultrasound Guidance Console…Boston Scientific Corporation20230—
+4K182188Ion Endoluminal System ; Flexision Biopsy NeedleIntuitive Surgical2019125
+5K221206Compass Steerable NeedleSerpex Medical, Inc.20221—
+5K202370Ion Endoluminal SystemIntuitive Surgical, Inc.20205—
+5K192367Ion Endoluminal SystemIntuitive Surgical, Inc.20193—
+6K252874Compass Steerable Needle with Adapters SRA-1-01 and SRA-2-01Serpex Medical, Inc.20250—
+6K220299Ion Endoluminal System (IF1000)Intuitive Surgical, Inc.20224—
+6K201146Ion Endoluminal SystemIntuitive Surgical, Inc.20202—
+7K232984Ion Endoluminal System (IF1000)Intuitive Surgical, Inc.20233—
+7K212048Ion Endoluminal System (Ion Fully Articulating Catheter), Ion Endoluminal System (Ion…Intuitive Surgical, Inc.202111
+8K242070Ion Endoluminal System (IF 1000)Intuitive Surgical, Inc.20242—
+8K240135Ion™ Endoluminal System (Ion™ Fully Articulating Catheter) (IF1000)Intuitive Surgical, Inc.20240—
+9K252045Ion Endoluminal System (IF1000)Intuitive Surgical, Inc.20250—
+9K252528Ion Endoluminal System (IF1000)Intuitive Surgical, Inc.20250—