510(k) Report

Devices descending from K161656

40 later devices reach Ambu aScope 3 Regular 5.0/2.2, Ambu aScope 3 Slim 3.8/1.2, Ambu aScope 3 Large… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K173727Ambu aScope 3 Slim 3.8/1.2 and Ambu aScope 4 Broncho Slim 3.8/1.2; Ambu aScope 3 Regular…Ambu A/S201839—
+2K260420LoopView® Single-Use Digital Flexible Bronchoscope (B27-C, B27-CG)MacroLux Medical Technology Co., Ltd.20260—
+2K251894Himaging Bronchscope SystemHimaging Technology (Shanghai) Co., Ltd.20250—
+2K251823UE BRONCHO Single-Use Bronchoscopes (EBS-380C); UE BRONCHO Single-Use Bronchoscopes…Zhejiang UE Medical Corp.20250—
+2K242793Insighters™ Single-use Bronchoscope/Insight Bimodel-Integral iS-B12A 4.6/2.0…Shenzhen Insighters Medical Technology Co., Ltd.20250—
+2K234113MiiS Horus Bronchoscope; MiiS Horus Endoscope Display System -Tablet; MiiS Horus…Medimaging Integrated Solution, Inc (Miis)20240—
+2K233779LoopView® Single-Use Digital Flexible Bronchoscope (B38, B38-C, B50, B50-C, B58, B58-C)…MacroLux Medical Technology Co., Ltd.20240—
+2K222910Bronchoscope SystemShenzhen HugeMed Medical Technical Development Co., Ltd.20230—
+2K213235PENTAX Medical ONE Pulmo Single Use Video Bronchoscope SystemPentax of America, Inc.20221—
+2K220606Ambu aScope 5 Broncho HD 5.6/2.8, Ambu aScope 5 Broncho HD 5.0/2.2, Ambu aBox 2Ambu A/S202210—
+2K213782Single-Use Video Bronchoscopes, Digital ControllerMicro-Tech (Nanjing) Co., Lts20220—
+2K220399WiScope Digital Bronchoscope System, WiScope Single-Use Digital Flexible Bronchoscope…OTU Medical, Inc.20220—
+2K211169Bronchoscope SystemShanghai AnQing Medical Instrument Co., Ltd.20212—
+2K211030EXALT Model B Single-Use Bronchoscope (Slim), EXALT Model B Single-Use Bronchoscope…Boston Scientific Corporation20211—
+2K210883aScope 4 Broncho Regular Sampler Set 5.0/2.2, aScope 4 Broncho Large Sampler Set 5.8/2.8Ambu A/S20212—
+2K202180Broncoflex Agile; Product Reference: 20030001 , Broncoflex Vortex; Product Reference…Axess Vision Technology20201—
+2K191828Vathin Video Bronchoscope SystemHunan Vathin Medical Instrument Co., Ltd.20208—
+3K243497Portable Video Processor (EA101), Flexible Bronchoscope BS41H-12EU, BS41H-12US…Shanghai AnQing Medical Instrument Co., Ltd.20251—
+3K243541LumiRex BronchoscopeContra Healthcare Solutions, LLC20250—
+3K242010Bronchoscope System, The Single-use Bronchoscope (Single-use Bronchoscope: SP-Y-ZQGJ2.8…Shenzhen Sanping Image Technology Co., Ltd.20250—
+3K242416Single-use Flexible Bronchoscope: BC-E1C10, BC-E1C11, BC-E1C12, BC-E1E10, BC-E1E11…Hunan Vathin Medical Instrument Co., Ltd.20250—
+3K241612Video Bronchoscope System; Single-use Flexible Bronchoscope (BC-S1E00-L, BC-S1H00-L…Hunan Vathin Medical Instrument Co., Ltd.20240—
+3K231107Bronchoscope SystemHunan Endoso Life Technology Co., Ltd.20241—
+3K231970PENTAX Medical Single Use Video Bronchoscope EB11-S01, PENTAX Medical Single Use Video…Pentax of America, Inc.20240—
+3K230428Ambu® aScope™ 5 Broncho 2.7/1.2, Ambu® aScope™ 5 Broncho 4.2/2.2, Ambu® aBox™ 2Ambu A/S20234—
+3K223299Ambu® aScope™ 5 Broncho HD 5.0/2.2, Ambu® aScope™ 5 Broncho HD 5.6/2.8, Ambu® aView™ 2…Ambu A/S202361
+3K223782Ambu aScope 5 Broncho HD 5.6/2.8 Sampler Set, Ambu aScope 5 Broncho HD 5.0/2.2 Sampler SetAmbu A/S20230—
+3K222014EXALT Model B Single-Use BronchoscopeBoston Scientific Corporation20220—
+3K212886Broncoflex Agile, Broncoflex Vortex, ScreeniAxess Vision Technology20220—
+3K210379Broncho Videoscope SystemScivita Medical Technology Co., Ltd.20213—
+3K202346SPiN Vision Video Bronchoscope SystemVeran Medical Technologies, Inc.20210—
+4K253184Video Rhinolaryngoscope System (Disposable Video Rhinolaryngoscope SP11A Endoscopic…Zhuhai Wesee Meditech Co., Ltd.20260—
+4K251752Flexible Bronchoscope (BS27U-12EU, BS27U-12US, BS38U-20EU, BS38U-20US)Shanghai AnQing Medical Instrument Co., Ltd.20250—
+4K250210Broncho Videoscope System (Single-use Broncho Videoscope (SBV-1A-B, SBV-1A-P, SBV-1B-B…Scivita Medical Technology Co., Ltd.20250—
+4K240289Full HD Endoscopic Image Processor (HDVS-S200A, HDVS-S200B, HDVS-S200C, HDVS-S200D)Scivita Medical Technology Co., Ltd.20240—
+4K233671Ambu® aScope™ 5 Broncho 4.2/2.2; Ambu® aScope™ 5 Broncho 2.7/1.2; Ambu® aView™ 2 AdvanceAmbu A/S20242—
+4K231521Broncho Videoscope SystemScivita Medical Technology Co., Ltd.20231—
+4K232582Ambu® aScope™ 5 Broncho 4.2/2.2 Sampler SetAmbu A/S202311
+5K260309Ambu® aScope™ 5 Broncho 2.7/1.2; Ambu® aScope™ 5 Broncho 4.2/2.2; Ambu® aScope™ 5…Ambu A/S20260—
+5K242108Ambu® aScope™ 5 Uretero (Standard Deflection); Ambu® aScope™ 5 Uretero (Reverse…Ambu A/S20240—