FDA 510(k) Applications for Medical Device Product Code "EOQ"
(Bronchoscope (Flexible Or Rigid))
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K130845 | AMBU A/S | AMBU ASCOPE 3 5.0/2.2; AMBU ASCOPE 3 SLIM 3.8/1.2; AMBU AVIEW | 11/01/2013 |
| K161656 | AMBU A/S | Ambu aScope 3 Regular 5.0/2.2, Ambu aScope 3 Slim 3.8/1.2, Ambu aScope 3 Large 5.8/2.8, Ambu aView Monitor | 09/01/2016 |
| K173727 | Ambu A/S | Ambu aScope 3 Slim 3.8/1.2 and Ambu aScope 4 Broncho Slim 3.8/1.2; Ambu aScope 3 Regular 5.0/2.2 and Ambu aScope 4 Broncho Regular 5.0/2.2; Ambu aScope 3 Large 5.8/2.8 and Ambu aScope 4 Broncho Large 5.8/2.8; Ambu aView Monitor | 03/28/2018 |
| K223782 | Ambu A/S | Ambu aScope 5 Broncho HD 5.6/2.8 Sampler Set, Ambu aScope 5 Broncho HD 5.0/2.2 Sampler Set | 01/12/2023 |
| K220606 | Ambu A/S | Ambu aScope 5 Broncho HD 5.6/2.8, Ambu aScope 5 Broncho HD 5.0/2.2, Ambu aBox 2 | 07/25/2022 |
| K230428 | Ambu A/S | Ambu« aScopeÖ 5 Broncho 2.7/1.2, Ambu« aScopeÖ 5 Broncho 4.2/2.2, Ambu« aBoxÖ 2 | 08/10/2023 |
| K232582 | Ambu A/S | Ambu« aScopeÖ 5 Broncho 4.2/2.2 Sampler Set | 09/20/2023 |
| K223299 | Ambu A/S | Ambu« aScopeÖ 5 Broncho HD 5.0/2.2, Ambu« aScopeÖ 5 Broncho HD 5.6/2.8, Ambu« aViewÖ 2 Advance | 06/01/2023 |
| K210883 | Ambu A/S | aScope 4 Broncho Regular Sampler Set 5.0/2.2, aScope 4 Broncho Large Sampler Set 5.8/2.8 | 06/17/2021 |
| K202987 | Anrei Medical (Hangzhou) Co., Ltd | Rescue Pulmonary Grasping Forceps | 04/29/2021 |
| K022446 | AOMORI OLYMPUS CO., LTD. | MUCUS COLLECTION PROBE, MODELS BC-401C & BC-402C | 03/28/2003 |
| K211493 | Auris Health, Inc. | Monarch Platform | 07/09/2021 |
| K193534 | Auris Health, Inc. | Monarch Platform | 04/15/2020 |
| K152319 | AURIS SURGICAL ROBOTICS, INC. | Auris Robotic Endoscopy System (ARES) | 05/26/2016 |
| K173760 | Auris Surgical Robotics, Inc. | Monarch Endoscopy Platform (Monarch Platform) | 03/22/2018 |
| K212886 | Axess Vision Technology | Broncoflex Agile, Broncoflex Vortex, Screeni | 02/16/2022 |
| K202180 | Axess Vision Technology | Broncoflex Agile; Product Reference: 20030001 , Broncoflex Vortex; Product Reference: 10030001, Screeni; Product Reference: 30030001 | 10/22/2020 |
| K024165 | BISTECH, INC. | DUAL-LUMEN CATHETER | 01/10/2003 |
| K172955 | Body Vision Medical Ltd. | LungVision Tool | 04/26/2018 |
| K040018 | BOSTON SCIENTIFIC CORP. | EXCELON TRANSBRONCHIAL ASPIRATION NEEDLE, MODELS 6410, 6411, 6412 | 01/20/2004 |
| K963252 | BOSTON SCIENTIFIC CORP. | TBAN | 09/20/1996 |
| K183085 | Boston Scientific Corporation | CoreDxÖ Pulmonary Mini-Forceps | 03/08/2019 |
| K222014 | Boston Scientific Corporation | EXALT Model B Single-Use Bronchoscope | 07/28/2022 |
| K211030 | Boston Scientific Corporation | EXALT Model B Single-Use Bronchoscope (Slim), EXALT Model B Single-Use Bronchoscope (Regular), EXALT Model B Single-Use Bronchoscope (Large), EXALT Monitor | 08/09/2021 |
| K151315 | BOSTON SCIENTIFIC CORPORATION | Expect Pulmonary Endobronchial Ultrasound Transbronchial Aspiration Needle | 11/10/2015 |
| K163248 | Boston Scientific Corporation | Expect Pulmonary Endobronchial Ultrasound Transbronchial Aspiration Needle | 03/27/2017 |
| K221340 | Boston Scientific Corporation | iNod Ultrasound Guided Biopsy Needle (UPN: M00502060), iNod Ultrasound Guidance Console (UPN: M00503210) | 03/02/2023 |
| K131234 | BRONCUS MEDICAL INC | LUNGPOINT TOOLS (LUNGPOINT SHEATH, LUNGPOINT DILATION BALLOON) | 10/15/2013 |
| K200702 | Broncus Medical, Inc | EasyPath RF Introducer Sheath | 01/14/2021 |
| K980046 | BRONCUS TECHNOLOGIES, INC. | BRONCHIAL CATHETER SYSTEM | 05/01/1998 |
| K993900 | BRONCUS TECHNOLOGIES, INC. | COAGULATION ELECTRODE, MODEL 2000; RADIOFREQUENCY GENERATOR, MODEL 20-115 | 01/28/2000 |
| K013111 | BRONCUS TECHNOLOGIES, INC. | EXHALE PROBE | 10/01/2001 |
| K011267 | BRONCUS TECHNOLOGIES, INC. | EXHALE RF PROBE | 05/08/2001 |
| K090853 | BRONCUS TECHNOLOGIES, INC. | YIELD TISSUE SAMPLER | 04/07/2009 |
| K091250 | CARDINAL HEALTH, INC. | DIAGNOSTIC CATHETER SYSTEM | 05/22/2009 |
| K031966 | COOK, INC. | ENK FIBEROPTIC ATOMIZER SET | 10/16/2003 |
| K142934 | COVIDIEN | CrossCountry Transbronchial Access Tool straight, CrossCountry Transbronchial Access Tool curved | 06/17/2015 |
| K163537 | Covidien llc | Arcpoint pulmonary needle - 18 ga, Arcpoint pulmonary needle - 21 ga | 04/21/2017 |
| K142839 | Covidien LLC | GenCut Core Biopsy System | 04/29/2015 |
| K983878 | E. BENSON HOOD LABORATORIES, INC. | CZAJA-MCCAFFREY RIGID STENT INTRODUCER/ENDOSCOPE | 01/29/1999 |
| K183607 | FUJIFILM Corporation | FUJIFILM Bronchoscope | 08/23/2019 |
| K182825 | FUJIFILM Corporation | FUJIFILM Ultrasonic Endoscope | 02/22/2019 |
| K182253 | FUJIFILM Corporation | FUJIFILM Video Bronchoscopes | 04/04/2019 |
| K220957 | FUJIFILM Corporaton | FUJIFILM Endoscope Model EB-710P | 11/10/2022 |
| K122535 | FUJIFILM MEDICAL SYSTEM U.S.A., INC. | FUJINON/FUJIFILM EB-530 SERIES BRONCHOSCOPES (EB-530S, EB-530T AND EB-530H | 12/13/2012 |
| K121035 | FUJIFILM MEDICAL SYSTEM U.S.A., INC. | FUJINON/FUJIFILM ULTRASONIC ENDOSCOPE EB-530US | 06/04/2012 |
| K171291 | FUJIFILM Medical Systems U.S.A., Inc. | FUJIFILM Bronchoscope Model EB-530P | 01/19/2018 |
| K050907 | FUJINON, INC. | FUJINON G5 BRONCHOSCOPES, MODELS EB-470S, EB-250S, AND EB-270P | 05/19/2005 |
| K013731 | GIMMI GMBH | GIMMI ALPHA SINUSCOPES MODEL # E.8282.01/31/71 + E.8284.01/31/71; GIMMI ALPHA BRONCHOSCOPES MODEL # E.8189.00/01/02/03 | 11/27/2001 |
| K022546 | HORIZONS INTL. CORP. | HORIZONS ANSO TRANSBRONCHIAL ASPIRATION NEEDLES | 08/12/2002 |
| K191828 | Hunan Vathin Medical Instrument Co., Ltd. | Vathin Video Bronchoscope System | 02/13/2020 |
| K213635 | Hunan Vathin Medical Instrument Co., Ltd. | Vathin Video Bronchoscope System | 02/28/2022 |
| K223836 | Hunan Vathin Medical Instrument Co., Ltd. | Vathin« Video Bronchoscope System | 05/15/2023 |
| K182188 | Intuitive Surgical | Ion Endoluminal System ; Flexision Biopsy Needle | 02/14/2019 |
| K192367 | Intuitive Surgical, Inc. | Ion Endoluminal System | 11/26/2019 |
| K201146 | Intuitive Surgical, Inc. | Ion Endoluminal System | 06/26/2020 |
| K202370 | Intuitive Surgical, Inc. | Ion Endoluminal System | 11/16/2020 |
| K220299 | Intuitive Surgical, Inc. | Ion Endoluminal System (IF1000) | 06/16/2022 |
| K212048 | Intuitive Surgical, Inc. | Ion Endoluminal System (Ion Fully Articulating Catheter), Ion Endoluminal System (Ion Peripheral Vision Probe) | 08/26/2021 |
| K212656 | KARL STORZ Endoscopy America | Flexible Intubation Video Endoscope û Sterile (FIVE-S) | 12/29/2021 |
| K960791 | KARL STORZ ENDOSCOPY-AMERICA, INC. | KARL STORZ HUZLY HIGH-FREQUENCY CUTTING LOOPS | 03/11/1996 |
| K961178 | KARL STORZ ENDOSCOPY-AMERICA, INC. | KARL STORZ INTUBATION FIBERSCOPE | 05/14/1996 |
| K954797 | KARL STORZ ENDOSCOPY-AMERICA, INC. | KARL STORZ RHINO-LARYNGO-BRONCHO FIBERSCOPE, FIBERSCOPE FOR BRONCHOSCOPY | 01/17/1996 |
| K071530 | KARL STORZ ENDOSCOPY-AMERICA, INC. | KARL STORZ VIDEO FLEXIBLE VIDEO ENT ENDOSCOPE SYSTEM | 08/24/2007 |
| K982983 | LSVP INTL., INC. | LSVP INTERNATIONAL BIOPSY FORCEPS | 09/29/1998 |
| K131401 | MERCATOR MEDSYSTEMS, INC. | BLOWFISH TRANSBRONCHIAL MICRO-INFUSION CATHETER | 07/02/2013 |
| K213782 | Micro-Tech (Nanjing) Co., Lts | Single-Use Video Bronchoscopes, Digital Controller | 07/08/2022 |
| K960880 | MILL-ROSE LABORATORY | MILL-ROSE BLIND MICROBIOLOGY BRUSH | 04/29/1996 |
| K983122 | MILL-ROSE LABORATORY | MILL-ROSE LABORATORIES TRANSBRONCHIAL NEEDLE ASPIRATION (TBNA) COMBINATION CYTOLOGY/HISTOLOGY PROCEDURAL KIT | 10/30/1998 |
| K983124 | MILL-ROSE LABORATORY | MILL-ROSE LABORATORIES TRANSBRONCHIAL NEEDLE ASPIRATION (TBNA) CYTOLOGY PROCEDURAL KIT | 10/30/1998 |
| K962736 | MILL-ROSE LABORATORY | MILL-ROSE LARYNGOSCOPIC INJECTION NEEDLE | 07/29/1996 |
| K223144 | Noah Medical Corp. | Galaxy System | 03/01/2023 |
| K963033 | OLYMPUS AMERICA, INC. | BF 240/P240/IT240 BRONCHOVIDEOSCOPE & ACCESSORIES | 09/09/1996 |
| K962901 | OLYMPUS AMERICA, INC. | OLYMPUS B5-2C/B7-2C BALLOON CATHETER | 08/20/1996 |
| K962367 | OLYMPUS AMERICA, INC. | OLYMPUS BASKET GRASPERS | 08/05/1996 |
| K962380 | OLYMPUS AMERICA, INC. | OLYMPUS BF TYPE 200 VIDEO BRONCHSCOPES(BF-200/BF-P200/BF-IT200) | 08/09/1996 |
| K962555 | OLYMPUS AMERICA, INC. | OLYMPUS FB SERIES BIOPSY FORCEPS | 07/30/1996 |
| K962485 | OLYMPUS AMERICA, INC. | OLYMPUS FG SERIES OF RAT TOOTH GRASPING FORCEPS (ENT) | 08/20/1996 |
| K962378 | OLYMPUS AMERICA, INC. | OLYMPUS FG-45/46-1 GRASPING FORCEPS | 08/02/1996 |
| K962533 | OLYMPUS AMERICA, INC. | OLYPUS FG SERIES GRASPING FORCEPS | 08/09/1996 |
| K040940 | OLYMPUS CORPORATION | BRONCHOVIDEOSCOPE OLYMPUS XBF-D160HM | 04/19/2004 |
| K201300 | Olympus Medical Systems Corp. | Airway Mobilescope | 01/26/2021 |
| K172726 | Olympus Medical Systems Corp. | EVIS EXERA III BRONCHOFIBERVIDEOSCOPE OLYMPUS BF-MP190F, Single Use Biopsy Forceps FB-433D | 04/30/2018 |
| K201758 | Olympus Medical Systems Corp. | EVIS EXERA III Bronchovideoscope Olympus BF-XP190, EVIS EXERA III Bronchovideoscope Olympus BF-P190 | 01/21/2021 |
| K183419 | Olympus Medical Systems Corp. | EVIS EXERA III Bronchovideoscope Olympus BF-XT190 | 09/05/2019 |
| K121959 | OLYMPUS MEDICAL SYSTEMS CORP. | EVIS EXERA III VIDEO SYSTEM | 01/10/2013 |
| K200397 | Olympus Medical Systems Corp. | Single Use Biopsy Forceps FB-456D | 04/24/2020 |
| K200342 | Olympus Medical Systems Corp. | Single Use Grasping Forceps FG-214P, Single Use Grasping Forceps FG-220P, Single Use Grasping Forceps FG-226C, Single Use Grasping Forceps FG-232L, Single Use Grasping Forceps FG-804L | 12/17/2020 |
| K192164 | Olympus Medical Systems Corp. | Single Use Guide Sheath Kit K-401, K-402, & Single Use Guiding Device CC-220DR | 03/06/2020 |
| K212667 | Olympus Medical Systems Corp. | Single Use Guide Sheath Kit-401, K-402 | 09/22/2021 |
| K221631 | Olympus Medical Systems Corp. | Tracheal Intubation Fiberscope OLYMPUS LF-P, VISERA Tracheal Intubation Videoscope OLYMPUS LF Type V | 09/26/2022 |
| K061313 | OLYMPUS MEDICAL SYSTEMS CORPORATION | EVIS EXERA 180 SYSTEM | 08/31/2006 |
| K050220 | OLYMPUS MEDICAL SYSTEMS CORPORATION | EVIS EXERA BRONCHOVIDEOSCOPE, OLYMPUS XBF-160Y3AC, XBF-1T160Y3AC,XBF-Q160Y2AC | 02/10/2005 |
| K222861 | Olympus Medical Systems Corporation | EVIS XI Video System Center Olympus CV-1500, Bronchovideoscope Olympus BF-H1100, Bronchovideoscope Olympus BF-1TH1100 | 06/15/2023 |
| K060243 | OLYMPUS MEDICAL SYSTEMS CORPORATION | OLYMPUS GUIDE SHEATH, MODEL XBO1-836-13 | 06/23/2006 |
| K082720 | OLYMPUS MEDICAL SYSTEMS CORPORATION | TRACHEAL INTUBATION FIBERVIDEOSCOPE, MODELS LF-Y0004 AND LF-Y0005 | 11/05/2008 |
| K033225 | OLYMPUS OPTICAL CO., LTD. | EVIS EXERA BRONCHOFIBERVIDEOSCOPE OLYMPUS BF TYPE XP160F, ITS ACCESSORIES AND ANCILLARY EQUIPMENT | 10/16/2003 |
| K220399 | OTU Medical Inc. | WiScope Digital Bronchoscope System, WiScope Single-Use Digital Flexible Bronchoscope, WiScope Image System | 06/16/2022 |
| K131946 | PENTAX MEDICAL COMPANY | ENTAX ULTRASOUND VIDEO BRONCHOSCOPE EB-1970UK + HI VISIN PREIRUS | 04/25/2014 |
| K131028 | PENTAX MEDICAL COMPANY | PENTAX VIDEO BRONCHOSCOPES (EB FAMILY) | 04/10/2014 |
| K081518 | PENTAX MEDICAL COMPANY | ULTRASOUND VIDEO BRONCHOSCOPE, MODEL EB-1970UK | 09/05/2008 |
| K183654 | PENTAX of America, Inc. | PENTAX Medical EB-1970UK Ultrasound Video Bronchoscope + Hitachi NOBLUS and HI VISION Preirus | 05/23/2019 |
| K143727 | PENTAX OF AMERICA, INC. | PENTAX Medical EKP-i5010 Video Processor with EB Family | 10/29/2015 |
| K213235 | PENTAX of America, Inc. | PENTAX Medical ONE Pulmo Single Use Video Bronchoscope System | 12/21/2022 |
| K183516 | PENTAX of America, Inc. | PENTAX Medical Ultrasound Video Bronchoscope EB19-J10U | 09/06/2019 |
| K200678 | PENTAX of America, Inc. | PENTAX Medical Video Bronchoscope EB-J10 Series | 07/30/2020 |
| K210928 | PENTAX of America, Inc. | PENTAX Medical Video Bronchoscope EB11-J10 | 10/21/2021 |
| K173554 | PENTAX of America, Inc. | PENTAX Medical Video Bronchoscopes, PENTAX Medical Video Naso-Pharyngo-Laryngoscope, and PENTAX Medical Ultrasond Video Bronchoscope | 01/19/2018 |
| K023376 | PENTAX PRECISION INSTRUMENT CORP. | EB-1830T3, VIDEO BRONCHOSCOPE | 10/16/2002 |
| K990547 | PILLING WECK, INC. | PILLING WECK SURGICAL Y STENT FORCEPS | 04/27/1999 |
| K974642 | PLASTIMED LABORATOIRE PHARMACEUTIQUE | COMBICATH CATHETER | 03/13/1998 |
| K152466 | PROSURG, INC | Neo-Bronchoscope -Digital Video Bronchoscopy System(Rigid/Flexible) | 05/19/2016 |
| K150280 | SANOVAS, INC. | PulmoVia Working Channel | 06/11/2015 |
| K141366 | SCHOLLY FIBEROPTIC GMBH | VIDEO BRONCHOSCOPE SYSTEM | 12/17/2014 |
| K210379 | Scivita Medical Technology Co., Ltd. | Broncho Videoscope System | 07/28/2021 |
| K221302 | Serpex Medical, Inc. | Recon Steerable Sheath | 08/15/2022 |
| K211169 | Shanghai AnQing Medical Instrument CO., Ltd. | Bronchoscope System | 11/24/2021 |
| K222910 | Shenzhen HugeMed Medical Technical Development Co., Ltd | Bronchoscope System | 04/11/2023 |
| K171492 | Spiration, Inc. | B7 2C Occlusion Balloon | 11/20/2017 |
| K142909 | SPIRATION, INC. | Flexible 19G EBUS Needle | 04/24/2015 |
| K162611 | SPIRATION, INC. | PeriFLEX | 02/09/2017 |
| K071473 | SUPERDIMENSION, LTD. | MODIFICATION TO SUPERDIMENSION/BRONCHUS PREMIUM 2 | 07/12/2007 |
| K023984 | THE OLYMPUS OPTICAL CO. | MODIFICATION TO OLYMPUS BRONCHOSCOPES BF-40 SERIES, BF-240 SERIES, AND BF-160 SERIES | 01/31/2003 |
| K981543 | THE OLYMPUS OPTICAL CO. | OLYMPUS LF-TP AND LF-DP TRACHEAL INTUBATION FIBERSCOPES, ACCESSORIES AND ANCILLARY EQUIPMENT | 06/08/1998 |
| K012073 | THE OLYMPUS OPTICAL CO. | OLYMPUS SPRAY CATHETER PW-6C-1 | 08/10/2001 |
| K970107 | UROHEALTH SYSTEMS, INC. | INTUBATION ENDOSCOPE AND INTRODUCER SHEATH | 11/18/1997 |
| K202346 | Veran Medical Technologies, Inc. | SPiN Vision Video Bronchoscope System | 02/19/2021 |
| K230948 | Verathon Medical (Canada) ULC | BFlexÖ 2 Slim 3.8 Single-Use Bronchoscope | 05/03/2023 |
| K211947 | Verathon Medical (Canada) ULC | GlideScope BFlex 2.8 Single-Use Bronchoscope | 11/03/2021 |
| K193488 | Verathon Medical (Canada) ULC | GlideScope BFlex 3.8 Single-Use Bronchoscope | 01/16/2020 |
| K191948 | Verathon Medical (Canada) ULC | GlideScope BFlex 5.8 Single-Use Bronchoscope | 08/21/2019 |
| K183256 | Verathon Medical (Canada) ULC | GlideScope BFlex Single-Use Bronchoscope System | 01/04/2019 |
| K021344 | VISION-SCIENCES, INC. | B-F200 BRONCHOSCOPE WITH BSS-F21 ENDOSHEATH SYSTEM | 05/24/2002 |
| K091768 | VISION-SCIENCES, INC. | VIDEO SCIENCES BRS-5000 VIDEO BRONCHOSCOPE WITH ENDOSHEATH SYSTEM, DPU-5000/DPU-5050 VIDEO PROCESSOR & ACCESSORIES | 08/03/2009 |
| K963795 | VISION-SCIENCES, INC. | VISION-SCIENCES MODEL B-F100 BRONCHOSCOPE WITH MODEL BS-F21 DISPOSABLE ENDOSHEATH | 12/23/1996 |
| K163377 | Wilson-Cook Medical Inc. | Captura Disposable Bronchoscope Biopsy Forceps | 02/21/2018 |
| K984157 | WILSON-COOK MEDICAL, INC. | MODIFICATION TO WILSON-COOK LUNG BIOPSY NEEDLE | 12/08/1998 |
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