510(k) Report

Devices descending from K914181

38 later devices reach Wang/Mill-Rose Transbronchial Aspiration Needle through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K163537Arcpoint pulmonary needle - 18 ga, Arcpoint pulmonary needle - 21 gaCovidien, LLC201714—
+1K162611PeriFLEXSpiration, Inc.201712—
+1K142934CrossCountry Transbronchial Access Tool straight, CrossCountry Transbronchial Access…Covidien20152—
+1K142839GenCut Core Biopsy SystemCovidien, LLC201515—
+1K984157Modification to Wilson-Cook Lung Biopsy NeedleWilson-Cook Medical, Inc.19980—
+1K983122Mill-Rose Laboratories Transbronchial Needle Aspiration (Tbna) Combination…Mill-Rose Laboratory19980—
+1K983124Mill-Rose Laboratories Transbronchial Needle Aspiration (Tbna) Cytology Procedural KitMill-Rose Laboratory19980—
+1K963252TBANBoston Scientific Corp199619—
+1K962736Mill-Rose Laryngoscopic Injection NeedleMill-Rose Laboratory19960—
+2K260565SmartClip Delivery Catheter (ADR-1715)Elucent Medical20260—
+2K232601BroncTru™ Transbronchial Access ToolBroncus Medical, Inc.20240—
+2K221340iNod Ultrasound Guided Biopsy Needle (UPN: M00502060), iNod Ultrasound Guidance Console…Boston Scientific Corporation20230—
+2K182188Ion Endoluminal System ; Flexision Biopsy NeedleIntuitive Surgical2019125
+2K173760Monarch Endoscopy Platform (Monarch Platform)Auris Surgical Robotics, Inc.201871
+2K171232PeriView FLEXOlympus Surgical Technologies America20173—
+2K090853Yield Tissue SamplerBroncus Technologies, Inc.20090—
+2K040018Excelon Transbronchial Aspiration Needle, Models 6410, 6411, 6412Boston Scientific Corp200417—
+2K024165Dual-Lumen CatheterBistech, Inc.20030—
+3K223144Galaxy SystemNoah Medical Corp.202305
+3K221206Compass Steerable NeedleSerpex Medical, Inc.20221—
+3K202370Ion Endoluminal SystemIntuitive Surgical, Inc.20205—
+3K193534Monarch PlatformAuris Health, Inc.202054
+3K192367Ion Endoluminal SystemIntuitive Surgical, Inc.20193—
+3K181193PeriView FLEXOlympus Surgical Technologies America20180—
+4K252874Compass Steerable Needle with Adapters SRA-1-01 and SRA-2-01Serpex Medical, Inc.20250—
+4K231473Monarch BronchoscopeAuris Health, Inc., A Johnson and Johnson Family Company202301
+4K220299Ion Endoluminal System (IF1000)Intuitive Surgical, Inc.20224—
+4K211493Monarch PlatformAuris Health, Inc.202122
+4K203614Monarch BronchoscopeAuris Health, Inc., A Johnson and Johnson Family Company20211—
+4K201146Ion Endoluminal SystemIntuitive Surgical, Inc.20202—
+5K243219MONARCH™ Platform (MON-000008)Auris Health, Inc.202511
+5K232984Ion Endoluminal System (IF1000)Intuitive Surgical, Inc.20233—
+5K212048Ion Endoluminal System (Ion Fully Articulating Catheter), Ion Endoluminal System (Ion…Intuitive Surgical, Inc.202111
+6K260382MONARCH™ Platform (MON-000008)Auris Health, Inc.20260—
+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—