ClearanceBrief
Panels › Ear, Nose, Throat › Product code EOQ · Class 2

Bronchoscope (Flexible Or Rigid)

Regulation 874.4680

11510(k)s in 12 months (244 all time)
5recalls in 12 months (160 all time)
158recalls that name a 510(k)
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Top companies in EOQ

Company510(k)sRecalls
Olympus Corporation of the Americas0100
Olympus Medical Systems Corp.190
Intuitive Surgical116
Pentax of America, Inc.95
KARL STORZ Endoscopy-America, Inc.130
Ambu A/S110
Mill-Rose Laboratory110
Auris Health, Inc.46
Olympus America, Inc.100
Aomori Olympus Co., Ltd.18
Decided510(k)Device and applicantCode
Sep 23, 2026K261637Single-use Flexible Bronchoscope
Hunan Vathin Medical Instrument Co., Ltd., CN
EOQ
Sep 16, 2026K260309Ambu® aScope™ 5 Broncho 2.7/1.2; Ambu® aScope™ 5 Broncho 4.2/2.2; Ambu® aScope™ 5 Broncho 4.2/2.2 Sampler Set
Ambu A/S, DK
EOQ
Sep 2, 2026K2540263.8mm Slim ProVu Video Bronchoscope (090-02-0038U); 5.0mm Regular ProVu Video Bronchoscope (090-02-0050U); 6.0mm Large P
Flexicare Medical Limited., GB
EOQ
Jul 25, 2026K260382MONARCH™ Platform (MON-000008)
Auris Health, Inc.
EOQ
Jul 10, 2026K254037LungFlow Airway Catheter
Free Flow Medical, Inc.
EOQ
Jun 16, 2026K253137FUJIFILM Endoscope Model EB-840S; FUJIFILM Endoscope Model EB-840T
Fujifilm Corporation, JP
EOQ
May 14, 2026K260565SmartClip Delivery Catheter (ADR-1715)
Elucent Medical
EOQ
Apr 23, 2026K252341EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-Q190); EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-H190 ); EVIS EXERA III
Olympus Medical Systems Corp., JP
EOQ
Apr 8, 2026K260420LoopView® Single-Use Digital Flexible Bronchoscope (B27-C, B27-CG)
MacroLux Medical Technology Co., Ltd., CN
EOQ
Dec 12, 2025K250863FUJIFILM Ultrasonic Endoscope EB-710US
Fujifilm Corporation, JP
EOQ
Dec 5, 2025K251731KARL STORZ Flexible Intubation Video Endoscope – Sterile (FIVE-S) (0916612)
Karl Storz SE & CO. KG, DE
EOQ
Sep 23, 2025K252045Ion Endoluminal System (IF1000)
Intuitive Surgical, Inc.
EOQ
Sep 23, 2025K251894Himaging Bronchscope System
Himaging Technology (Shanghai) Co., Ltd., CN
EOQ
Sep 5, 2025K252528Ion Endoluminal System (IF1000)
Intuitive Surgical, Inc.
EOQ
Aug 27, 2025K251752Flexible Bronchoscope (BS27U-12EU, BS27U-12US, BS38U-20EU, BS38U-20US)
Shanghai AnQing Medical Instrument Co., Ltd., CN
EOQ
Aug 11, 2025K251823UE BRONCHO Single-Use Bronchoscopes (EBS-380C); UE BRONCHO Single-Use Bronchoscopes (EBS-500C); UE BRONCHO Single-Use Br
Zhejiang UE Medical Corp., CN
EOQ
Jul 25, 2025K250232Vathin® Video Bronchoscope System
Hunan Vathin Medical Instrument Co., Ltd., CN
EOQ
Jun 23, 2025K250862EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-XP190); EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-P190); EVIS EXERA III
Olympus Medical Systems Corp., JP
EOQ
Jun 13, 2025K244017FUJIFILM Endoscope Model EB-710P; FUJIFILM Processor EP-8000
Fujifilm Corporation, JP
EOQ
Jun 4, 2025K250118Disposable Balloon Catheter B5-2C
Olympus Medical Systems Corporation, JP
EOQ
May 30, 2025K250957Disposable Biopsy Forceps (FB-211D); Disposable Biopsy Forceps (FB-221D); Disposable Biopsy Forceps (FB-231D); Disposabl
Olympus Medical Systems Corporation, JP
EOQ
May 29, 2025K243497Portable Video Processor (EA101), Flexible Bronchoscope BS41H-12EU, BS41H-12US, BS46H-17EU, BS50H-20EU, BS46H-17US, BS50
Shanghai AnQing Medical Instrument Co., Ltd., CN
EOQ
May 28, 2025K242793Insighters™ Single-use Bronchoscope/Insight Bimodel-Integral iS-B12A 4.6/2.0; Insighters™ Single-use Bronchoscope/Insigh
Shenzhen Insighters Medical Technology Co., Ltd., CN
EOQ
Apr 30, 2025K243541LumiRex Bronchoscope
Contra Healthcare Solutions, LLC
EOQ
Mar 19, 2025K250210Broncho Videoscope System (Single-use Broncho Videoscope (SBV-1A-B, SBV-1A-P, SBV-1B-B, SBV-1B-P, SBV-1C-B, SBV-1C-P);
Scivita Medical Technology Co., Ltd., CN
EOQ
Mar 14, 2025K242010Bronchoscope System, The Single-use Bronchoscope (Single-use Bronchoscope: SP-Y-ZQGJ2.8, SP-Y-ZQGJ3.8, SP-Y-ZQGJ4.2, SP-
Shenzhen Sanping Image Technology Co., Ltd., CN
EOQ
Feb 6, 2025K242324DUTAU-NOVATECH®
Novatech SA, FR
EOQ
Jan 23, 2025K243219MONARCH™ Platform (MON-000008)
Auris Health, Inc.
EOQ
Jan 16, 2025K242416Single-use Flexible Bronchoscope: BC-E1C10, BC-E1C11, BC-E1C12, BC-E1E10, BC-E1E11, BC-E1E12, BC-E1H10, BC-E1H11, BC-E1H
Hunan Vathin Medical Instrument Co., Ltd., CN
EOQ
Oct 29, 2024K241612Video Bronchoscope System; Single-use Flexible Bronchoscope (BC-S1E00-L, BC-S1H00-L, BC-S1J00-L, BC-S1E00, BC-S1H00, BC-
Hunan Vathin Medical Instrument Co., Ltd., CN
EOQ
Oct 23, 2024K240289Full HD Endoscopic Image Processor (HDVS-S200A, HDVS-S200B, HDVS-S200C, HDVS-S200D)
Scivita Medical Technology Co., Ltd., CN
EOQ
Sep 24, 2024K242070Ion Endoluminal System (IF 1000)
Intuitive Surgical, Inc.
EOQ
May 31, 2024K232601BroncTru™ Transbronchial Access Tool
Broncus Medical, Inc.
EOQ
May 1, 2024K234113MiiS Horus Bronchoscope; MiiS Horus Endoscope Display System -Tablet; MiiS Horus Endoscope Display System -Video Box
Medimaging Integrated Solution, Inc (Miis), TW
EOQ
Apr 26, 2024K232038BioStar Single Use Transbronchial Aspiration Needle
Broncus Medical, Inc.
EOQ
Apr 5, 2024K233779LoopView® Single-Use Digital Flexible Bronchoscope (B38, B38-C, B50, B50-C, B58, B58-C), ViewHub® Video Processor (S13)
MacroLux Medical Technology Co., Ltd., CN
EOQ
Apr 3, 2024K240135Ion™ Endoluminal System (Ion™ Fully Articulating Catheter) (IF1000)
Intuitive Surgical, Inc.
EOQ
Feb 15, 2024K231107Bronchoscope System
Hunan Endoso Life Technology Co., Ltd., CN
EOQ
Feb 7, 2024K240075FUJIFILM Endoscope Model EB-710XT
FUJIFILM Healthcare Americas Corporation
EOQ
Jan 18, 2024K232860PENTAX Medical Video Processor EPK-i8020c, PENTAX Medical Video Bronchoscope EB11-J10, PENTAX Medical Video Bronchoscope
Pentax of America, Inc.
EOQ
Jan 12, 2024K231970PENTAX Medical Single Use Video Bronchoscope EB11-S01, PENTAX Medical Single Use Video Bronchoscope EB15-S01, PENTAX Med
Pentax of America, Inc.
EOQ
Jan 4, 2024K233671Ambu® aScope™ 5 Broncho 4.2/2.2; Ambu® aScope™ 5 Broncho 2.7/1.2; Ambu® aView™ 2 Advance
Ambu A/S, DK
EOQ
Dec 18, 2023K232984Ion Endoluminal System (IF1000)
Intuitive Surgical, Inc.
EOQ
Nov 14, 2023K231521Broncho Videoscope System
Scivita Medical Technology Co., Ltd., CN
EOQ
Sep 20, 2023K232582Ambu® aScope™ 5 Broncho 4.2/2.2 Sampler Set
Ambu A/S, DK
EOQ
Aug 10, 2023K230428Ambu® aScope™ 5 Broncho 2.7/1.2, Ambu® aScope™ 5 Broncho 4.2/2.2, Ambu® aBox™ 2
Ambu A/S, DK
EOQ
Jun 15, 2023K222861EVIS XI Video System Center Olympus CV-1500, Bronchovideoscope Olympus BF-H1100, Bronchovideoscope Olympus BF-1TH1100
Olympus Medical Systems Corporation, JP
EOQ
Jun 1, 2023K223299Ambu® aScope™ 5 Broncho HD 5.0/2.2, Ambu® aScope™ 5 Broncho HD 5.6/2.8, Ambu® aView™ 2 Advance
Ambu A/S, DK
EOQ
May 15, 2023K223836Vathin® Video Bronchoscope System
Hunan Vathin Medical Instrument Co., Ltd., CN
EOQ
May 3, 2023K230948BFlex™ 2 Slim 3.8 Single-Use Bronchoscope
Verathon Medical (Canada) Ulc, CA
EOQ

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