510(k) Report

Devices descending from K040018

17 later devices reach Excelon Transbronchial Aspiration Needle, Models 6410, 6411, 6412 through their predicates, nearest generation first.

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