510(k) Report

Devices descending from K142839

15 later devices reach GenCut Core Biopsy System through their predicates, nearest generation first.

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