EOQ · Bronchoscope (Flexible Or Rigid)
Ear, Nose, Throat · 21 CFR 874.4680 · Class 2
Overview
| Product Code | EOQ |
|---|---|
| Device Name | Bronchoscope (Flexible Or Rigid) |
| Regulation | 21 CFR 874.4680 |
| Device Class | Class 2 |
| Review Panel | Ear, Nose, Throat |
Identification
A bronchoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the bronchoscope and is intended to examine or treat the larynx and tracheobronchial tree. It is typically used with a fiberoptic light source and carrier to provide illumination. The device is made of materials such as stainless steel or flexible plastic. This generic type of device includes the rigid ventilating bronchoscope, rigid nonventilating bronchoscope, nonrigid bronchoscope, laryngeal-bronchial telescope, flexible foreign body claw, bronchoscope tubing, flexible biopsy forceps, rigid biopsy curette, flexible biopsy brush, rigid biopsy forceps, flexible biopsy curette, and rigid bronchoscope aspirating tube, but excludes the fiberoptic light source and carrier.
Classification Rationale
Class II.
Cleared Devices (236)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K260420 | LoopView® Single-Use Digital Flexible Bronchoscope (B27-C, B27-CG) | MacroLux Medical Technology Co., Ltd. | Apr 8, 2026 | SESE |
| K250863 | FUJIFILM Ultrasonic Endoscope EB-710US | Fujifilm Corporation | Dec 12, 2025 | SESE |
| K251731 | KARL STORZ Flexible Intubation Video Endoscope Sterile (FIVE-S) (0916612) | Karl Storz SE & CO. KG | Dec 5, 2025 | SESE |
| K252045 | Ion Endoluminal System (IF1000) | Intuitive Surgical, Inc. | Sep 23, 2025 | SESE |
| K251894 | Himaging Bronchscope System | Himaging Technology (Shanghai) Co., Ltd. | Sep 23, 2025 | SESE |
| K252528 | Ion Endoluminal System (IF1000) | Intuitive Surgical, Inc. | Sep 5, 2025 | SESE |
| K251752 | Flexible Bronchoscope (BS27U-12EU, BS27U-12US, BS38U-20EU, BS38U-20US) | Shanghai AnQing Medical Instrument Co., Ltd. | Aug 27, 2025 | SESE |
| K251823 | UE BRONCHO Single-Use Bronchoscopes (EBS-380C); UE BRONCHO Single-Use Bronchoscopes (EBS-500C); UE BRONCHO Single-Use Bronchoscopes (EBS-600C); UE Display (UE-M10S) | Zhejiang UE Medical Corp. | Aug 11, 2025 | SESE |
| K250232 | Vathin® Video Bronchoscope System | Hunan Vathin Medical Instrument Co., Ltd. | Jul 25, 2025 | SESE |
| K250862 | EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-XP190); EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-P190); EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-XT190); BRONCHOVIDEOSCOPE (OLYMPUS BF-H1100); BRONCHOVIDEOSCOPE (OLYMPUS BF-1TH1100) | Olympus Medical Systems Corp. | Jun 23, 2025 | SESE |
| K244017 | FUJIFILM Endoscope Model EB-710P; FUJIFILM Processor EP-8000 | Fujifilm Corporation | Jun 13, 2025 | SESE |
| K250118 | Disposable Balloon Catheter B5-2C | Olympus Medical Systems Corporation | Jun 4, 2025 | SESE |
| K250957 | Disposable Biopsy Forceps (FB-211D); Disposable Biopsy Forceps (FB-221D); Disposable Biopsy Forceps (FB-231D); Disposable Biopsy Forceps (FB-241D) | Olympus Medical Systems Corporation | May 30, 2025 | SESE |
| K243497 | Portable Video Processor (EA101), Flexible Bronchoscope BS41H-12EU, BS41H-12US, BS46H-17EU, BS50H-20EU, BS46H-17US, BS50H-20US, BS53H-22EU, BS53H-22US, BS55H-24EU, BS55H-24US, BS59H-28EU, BS59H-28US | Shanghai AnQing Medical Instrument Co., Ltd. | May 29, 2025 | SESE |
| K242793 | Insighters Single-use Bronchoscope/Insight Bimodel-Integral iS-B12A 4.6/2.0; Insighters Single-use Bronchoscope/Insight Bimodel-Integral iS-B22A 5.5 /2.6; Insighters Single-use Bronchoscope/Insight Bimodel-Integral iS-B26A 6.0/3.0; Insighters Insight Workstation iS-PF1. | Shenzhen Insighters Medical Technology Co., Ltd. | May 28, 2025 | SESE |
| K243541 | LumiRex Bronchoscope | Contra Healthcare Solutions, LLC | Apr 30, 2025 | SESE |
| K250210 | Broncho Videoscope System (Single-use Broncho Videoscope (SBV-1A-B, SBV-1A-P, SBV-1B-B, SBV-1B-P, SBV-1C-B, SBV-1C-P); Full HD Visualization Endoscopic Image Processor (HDVS-S300A, HDVS-S300B, HDVS-S300C, HDVS-S300D); Endoscopic Image Processor (HDVS-S100A, HDVS-S100D)) | Scivita Medical Technology Co., Ltd. | Mar 19, 2025 | SESE |
| K242010 | Bronchoscope System, The Single-use Bronchoscope (Single-use Bronchoscope: SP-Y-ZQGJ2.8, SP-Y-ZQGJ3.8, SP-Y-ZQGJ4.2, SP-Y-ZQGJ4.8, SP-Y-ZQGJ5.2, SP-Y-ZQGJ5.8; Electronic Endoscope Imaging Processor: SP-TXCLQ12.1) | Shenzhen Sanping Image Technology Co., Ltd. | Mar 14, 2025 | SESE |
| K242324 | DUTAU-NOVATECH® | Novatech SA | Feb 6, 2025 | SESE |
| K243219 | MONARCH Platform (MON-000008) | Auris Health, Inc. | Jan 23, 2025 | SESE |
| K242416 | Single-use Flexible Bronchoscope: BC-E1C10, BC-E1C11, BC-E1C12, BC-E1E10, BC-E1E11, BC-E1E12, BC-E1H10, BC-E1H11, BC-E1H12; Digital Video Monitor: DVM-D1, DVM-D2; Single-use sampler: S-20mL, S-30mL, S-50mL | Hunan Vathin Medical Instrument Co., Ltd. | Jan 16, 2025 | SESE |
| K241612 | Video Bronchoscope System; Single-use Flexible Bronchoscope (BC-S1E00-L, BC-S1H00-L, BC-S1J00-L, BC-S1E00, BC-S1H00, BC-S1J00.); Digital Video Monitor (DVM-D1, DVM-D2) | Hunan Vathin Medical Instrument Co., Ltd. | Oct 29, 2024 | SESE |
| K240289 | Full HD Endoscopic Image Processor (HDVS-S200A, HDVS-S200B, HDVS-S200C, HDVS-S200D) | Scivita Medical Technology Co., Ltd. | Oct 23, 2024 | SESE |
| K242070 | Ion Endoluminal System (IF 1000) | Intuitive Surgical, Inc. | Sep 24, 2024 | SESE |
| K232601 | BroncTru Transbronchial Access Tool | Broncus Medical, Inc. | May 31, 2024 | SESE |
| K234113 | MiiS Horus Bronchoscope; MiiS Horus Endoscope Display System -Tablet; MiiS Horus Endoscope Display System -Video Box | Medimaging Integrated Solution, Inc (Miis) | May 1, 2024 | SESE |
| K232038 | BioStar Single Use Transbronchial Aspiration Needle | Broncus Medical, Inc. | Apr 26, 2024 | SESE |
| K233779 | LoopView® Single-Use Digital Flexible Bronchoscope (B38, B38-C, B50, B50-C, B58, B58-C), ViewHub® Video Processor (S13) | MacroLux Medical Technology Co., Ltd. | Apr 5, 2024 | SESE |
| K240135 | Ion Endoluminal System (Ion Fully Articulating Catheter) (IF1000) | Intuitive Surgical, Inc. | Apr 3, 2024 | SESE |
| K231107 | Bronchoscope System | Hunan Endoso Life Technology Co., Ltd. | Feb 15, 2024 | SESE |
| K240075 | FUJIFILM Endoscope Model EB-710XT | FUJIFILM Healthcare Americas Corporation | Feb 7, 2024 | SESE |
| K232860 | PENTAX Medical Video Processor EPK-i8020c, PENTAX Medical Video Bronchoscope EB11-J10, PENTAX Medical Video Bronchoscope EB15-J10, PENTAX Medical Video Bronchoscope EB19-J10U, PENTAX Medical Ultrasound Video Bronchoscope EB19-J10U | Pentax of America, Inc. | Jan 18, 2024 | SESE |
| K231970 | PENTAX Medical Single Use Video Bronchoscope EB11-S01, PENTAX Medical Single Use Video Bronchoscope EB15-S01, PENTAX Medical Mobile Processor ONE-M, PENTAX Medical Mobile Processor Plug-In ONE-Dock | Pentax of America, Inc. | Jan 12, 2024 | SESE |
| K233671 | Ambu® aScope 5 Broncho 4.2/2.2; Ambu® aScope 5 Broncho 2.7/1.2; Ambu® aView 2 Advance | Ambu A/S | Jan 4, 2024 | SESE |
| K232984 | Ion Endoluminal System (IF1000) | Intuitive Surgical, Inc. | Dec 18, 2023 | SESE |
| K231521 | Broncho Videoscope System | Scivita Medical Technology Co., Ltd. | Nov 14, 2023 | SESE |
| K232582 | Ambu® aScope 5 Broncho 4.2/2.2 Sampler Set | Ambu A/S | Sep 20, 2023 | SESE |
| K230428 | Ambu® aScope 5 Broncho 2.7/1.2, Ambu® aScope 5 Broncho 4.2/2.2, Ambu® aBox 2 | Ambu A/S | Aug 10, 2023 | SESE |
| K222861 | EVIS XI Video System Center Olympus CV-1500, Bronchovideoscope Olympus BF-H1100, Bronchovideoscope Olympus BF-1TH1100 | Olympus Medical Systems Corporation | Jun 15, 2023 | SESE |
| K223299 | Ambu® aScope 5 Broncho HD 5.0/2.2, Ambu® aScope 5 Broncho HD 5.6/2.8, Ambu® aView 2 Advance | Ambu A/S | Jun 1, 2023 | SESE |
| K223836 | Vathin® Video Bronchoscope System | Hunan Vathin Medical Instrument Co., Ltd. | May 15, 2023 | SESE |
| K230948 | BFlex 2 Slim 3.8 Single-Use Bronchoscope | Verathon Medical (Canada) Ulc | May 3, 2023 | SESE |
| K222910 | Bronchoscope System | Shenzhen HugeMed Medical Technical Development Co., Ltd. | Apr 11, 2023 | SESE |
| K221340 | iNod Ultrasound Guided Biopsy Needle (UPN: M00502060), iNod Ultrasound Guidance Console (UPN: M00503210) | Boston Scientific Corporation | Mar 2, 2023 | SESE |
| K223144 | Galaxy System | Noah Medical Corp. | Mar 1, 2023 | SESE |
| K223782 | Ambu aScope 5 Broncho HD 5.6/2.8 Sampler Set, Ambu aScope 5 Broncho HD 5.0/2.2 Sampler Set | Ambu A/S | Jan 12, 2023 | SESE |
| K213235 | PENTAX Medical ONE Pulmo Single Use Video Bronchoscope System | Pentax of America, Inc. | Dec 21, 2022 | SESE |
| K220957 | FUJIFILM Endoscope Model EB-710P | Fujifilm Corporaton | Nov 10, 2022 | SESE |
| K221631 | Tracheal Intubation Fiberscope OLYMPUS LF-P, VISERA Tracheal Intubation Videoscope OLYMPUS LF Type V | Olympus Medical Systems Corp. | Sep 26, 2022 | SESE |
| K221302 | Recon Steerable Sheath | Serpex Medical, Inc. | Aug 15, 2022 | SESE |
| K222014 | EXALT Model B Single-Use Bronchoscope | Boston Scientific Corporation | Jul 28, 2022 | SESE |
| K220606 | Ambu aScope 5 Broncho HD 5.6/2.8, Ambu aScope 5 Broncho HD 5.0/2.2, Ambu aBox 2 | Ambu A/S | Jul 25, 2022 | SESE |
| K213782 | Single-Use Video Bronchoscopes, Digital Controller | Micro-Tech (Nanjing) Co., Lts | Jul 8, 2022 | SESE |
| K220399 | WiScope Digital Bronchoscope System, WiScope Single-Use Digital Flexible Bronchoscope, WiScope Image System | OTU Medical, Inc. | Jun 16, 2022 | SESE |
| K220299 | Ion Endoluminal System (IF1000) | Intuitive Surgical, Inc. | Jun 16, 2022 | SESE |
| K213635 | Vathin Video Bronchoscope System | Hunan Vathin Medical Instrument Co., Ltd. | Feb 28, 2022 | SESE |
| K212886 | Broncoflex Agile, Broncoflex Vortex, Screeni | Axess Vision Technology | Feb 16, 2022 | SESE |
| K212656 | Flexible Intubation Video Endoscope Sterile (FIVE-S) | Karl Storz Endoscopy America | Dec 29, 2021 | SESE |
| K211169 | Bronchoscope System | Shanghai AnQing Medical Instrument Co., Ltd. | Nov 24, 2021 | SESE |
| K211947 | GlideScope BFlex 2.8 Single-Use Bronchoscope | Verathon Medical (Canada) Ulc | Nov 3, 2021 | SESE |
| K210928 | PENTAX Medical Video Bronchoscope EB11-J10 | Pentax of America, Inc. | Oct 21, 2021 | SESE |
| K212667 | Single Use Guide Sheath Kit-401, K-402 | Olympus Medical Systems Corp. | Sep 22, 2021 | SESE |
| K212048 | Ion Endoluminal System (Ion Fully Articulating Catheter), Ion Endoluminal System (Ion Peripheral Vision Probe) | Intuitive Surgical, Inc. | Aug 26, 2021 | SESE |
| K211030 | EXALT Model B Single-Use Bronchoscope (Slim), EXALT Model B Single-Use Bronchoscope (Regular), EXALT Model B Single-Use Bronchoscope (Large), EXALT Monitor | Boston Scientific Corporation | Aug 9, 2021 | SESE |
| K210379 | Broncho Videoscope System | Scivita Medical Technology Co., Ltd. | Jul 28, 2021 | SESE |
| K211493 | Monarch Platform | Auris Health, Inc. | Jul 9, 2021 | SESE |
| K210883 | aScope 4 Broncho Regular Sampler Set 5.0/2.2, aScope 4 Broncho Large Sampler Set 5.8/2.8 | Ambu A/S | Jun 17, 2021 | SESE |
| K202987 | Rescue Pulmonary Grasping Forceps | Anrei Medical (Hangzhou) Co., Ltd. | Apr 29, 2021 | SESE |
| K202346 | SPiN Vision Video Bronchoscope System | Veran Medical Technologies, Inc. | Feb 19, 2021 | SESE |
| K201300 | Airway Mobilescope | Olympus Medical Systems Corp. | Jan 26, 2021 | SESE |
| K201758 | EVIS EXERA III Bronchovideoscope Olympus BF-XP190, EVIS EXERA III Bronchovideoscope Olympus BF-P190 | Olympus Medical Systems Corp. | Jan 21, 2021 | SESE |
| K200702 | EasyPath RF Introducer Sheath | Broncus Medical, Inc. | Jan 14, 2021 | SESE |
| K200342 | 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 | Olympus Medical Systems Corp. | Dec 17, 2020 | SESE |
| K202370 | Ion Endoluminal System | Intuitive Surgical, Inc. | Nov 16, 2020 | SESE |
| K202180 | Broncoflex Agile; Product Reference: 20030001 , Broncoflex Vortex; Product Reference: 10030001, Screeni; Product Reference: 30030001 | Axess Vision Technology | Oct 22, 2020 | SESE |
| K200678 | PENTAX Medical Video Bronchoscope EB-J10 Series | Pentax of America, Inc. | Jul 30, 2020 | SESE |
| K201146 | Ion Endoluminal System | Intuitive Surgical, Inc. | Jun 26, 2020 | SESE |
| K200397 | Single Use Biopsy Forceps FB-456D | Olympus Medical Systems Corp. | Apr 24, 2020 | SESE |
| K193534 | Monarch Platform | Auris Health, Inc. | Apr 15, 2020 | SESE |
| K192164 | Single Use Guide Sheath Kit K-401, K-402, & Single Use Guiding Device CC-220DR | Olympus Medical Systems Corp. | Mar 6, 2020 | SESE |
| K191828 | Vathin Video Bronchoscope System | Hunan Vathin Medical Instrument Co., Ltd. | Feb 13, 2020 | SESE |
| K193488 | GlideScope BFlex 3.8 Single-Use Bronchoscope | Verathon Medical (Canada) Ulc | Jan 16, 2020 | SESE |
| K192367 | Ion Endoluminal System | Intuitive Surgical, Inc. | Nov 26, 2019 | SESE |
| K183516 | PENTAX Medical Ultrasound Video Bronchoscope EB19-J10U | Pentax of America, Inc. | Sep 6, 2019 | SESE |
| K183419 | EVIS EXERA III Bronchovideoscope Olympus BF-XT190 | Olympus Medical Systems Corp. | Sep 5, 2019 | SESE |
| K183607 | FUJIFILM Bronchoscope | Fujifilm Corporation | Aug 23, 2019 | SESE |
| K191948 | GlideScope BFlex 5.8 Single-Use Bronchoscope | Verathon Medical (Canada) Ulc | Aug 21, 2019 | SESE |
| K183654 | PENTAX Medical EB-1970UK Ultrasound Video Bronchoscope + Hitachi NOBLUS and HI VISION Preirus | Pentax of America, Inc. | May 23, 2019 | SESE |
| K182253 | FUJIFILM Video Bronchoscopes | Fujifilm Corporation | Apr 4, 2019 | SESE |
| K183085 | CoreDx Pulmonary Mini-Forceps | Boston Scientific Corporation | Mar 8, 2019 | SESE |
| K182825 | FUJIFILM Ultrasonic Endoscope | Fujifilm Corporation | Feb 22, 2019 | SESE |
| K182188 | Ion Endoluminal System ; Flexision Biopsy Needle | Intuitive Surgical | Feb 14, 2019 | SESE |
| K183256 | GlideScope BFlex Single-Use Bronchoscope System | Verathon Medical (Canada) Ulc | Jan 4, 2019 | SESE |
| K172726 | EVIS EXERA III BRONCHOFIBERVIDEOSCOPE OLYMPUS BF-MP190F, Single Use Biopsy Forceps FB-433D | Olympus Medical Systems Corp. | Apr 30, 2018 | SESE |
| K172955 | LungVision Tool | Bodyvision Medical , Ltd. | Apr 26, 2018 | SESE |
| K173727 | 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 | Ambu A/S | Mar 28, 2018 | SESE |
| K173760 | Monarch Endoscopy Platform (Monarch Platform) | Auris Surgical Robotics, Inc. | Mar 22, 2018 | SESE |
| K163377 | Captura Disposable Bronchoscope Biopsy Forceps | Wilson-Cook Medical, Inc. | Feb 21, 2018 | SESE |
| K173554 | PENTAX Medical Video Bronchoscopes, PENTAX Medical Video Naso-Pharyngo-Laryngoscope, and PENTAX Medical Ultrasond Video Bronchoscope | Pentax of America, Inc. | Jan 19, 2018 | SESE |
| K171291 | FUJIFILM Bronchoscope Model EB-530P | Fujifilm Medical Systems U.S.A, Inc. | Jan 19, 2018 | SESE |
| K171492 | B7 2C Occlusion Balloon | Spiration, Inc. | Nov 20, 2017 | SESE |
| K163537 | Arcpoint pulmonary needle - 18 ga, Arcpoint pulmonary needle - 21 ga | Covidien, LLC | Apr 21, 2017 | SESE |
| K163248 | Expect Pulmonary Endobronchial Ultrasound Transbronchial Aspiration Needle | Boston Scientific Corporation | Mar 27, 2017 | SESE |
| K162611 | PeriFLEX | Spiration, Inc. | Feb 9, 2017 | SESE |
| K161656 | 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 | Ambu A/S | Sep 1, 2016 | SESE |
| K152319 | Auris Robotic Endoscopy System (ARES) | Auris Surgical Robotics, Inc. | May 26, 2016 | SESE |
| K152466 | Neo-Bronchoscope -Digital Video Bronchoscopy System(Rigid/Flexible) | Prosurg, Inc. | May 19, 2016 | SESE |
| K151315 | Expect Pulmonary Endobronchial Ultrasound Transbronchial Aspiration Needle | Boston Scientific Corporation | Nov 10, 2015 | SESE |
| K143727 | PENTAX Medical EKP-i5010 Video Processor with EB Family | Pentax of America, Inc. | Oct 29, 2015 | SESE |
| K142934 | CrossCountry Transbronchial Access Tool straight, CrossCountry Transbronchial Access Tool curved | Covidien | Jun 17, 2015 | SESE |
| K150280 | PulmoVia Working Channel | Sanovas, Inc. | Jun 11, 2015 | SESE |
| K142839 | GenCut Core Biopsy System | Covidien, LLC | Apr 29, 2015 | SESE |
| K142909 | Flexible 19G EBUS Needle | Spiration, Inc. | Apr 24, 2015 | SESE |
| K141366 | VIDEO BRONCHOSCOPE SYSTEM | Scholly Fiberoptic GmbH | Dec 17, 2014 | SESE |
| K131946 | ENTAX ULTRASOUND VIDEO BRONCHOSCOPE EB-1970UK + HI VISIN PREIRUS | Pentax Medical Company | Apr 25, 2014 | SESE |
| K131028 | PENTAX VIDEO BRONCHOSCOPES (EB FAMILY) | Pentax Medical Company | Apr 10, 2014 | SESE |
| K130845 | AMBU ASCOPE 3 5.0/2.2; AMBU ASCOPE 3 SLIM 3.8/1.2; AMBU AVIEW | Ambu A/S | Nov 1, 2013 | SESE |
| K131234 | LUNGPOINT TOOLS (LUNGPOINT SHEATH, LUNGPOINT DILATION BALLOON) | Broncus Medical, Inc. | Oct 15, 2013 | SESE |
| K131401 | BLOWFISH TRANSBRONCHIAL MICRO-INFUSION CATHETER | Mercator Medsystems, Inc. | Jul 2, 2013 | SESE |
| K121959 | EVIS EXERA III VIDEO SYSTEM | Olympus Medical Systems Corp. | Jan 10, 2013 | SESE |
| K122535 | FUJINON/FUJIFILM EB-530 SERIES BRONCHOSCOPES (EB-530S, EB-530T AND EB-530H | Fujifilm Medical System U.S.A., Inc. | Dec 13, 2012 | SESE |
| K121035 | FUJINON/FUJIFILM ULTRASONIC ENDOSCOPE EB-530US | Fujifilm Medical System U.S.A., Inc. | Jun 4, 2012 | SESE |
| K091768 | VIDEO SCIENCES BRS-5000 VIDEO BRONCHOSCOPE WITH ENDOSHEATH SYSTEM, DPU-5000/DPU-5050 VIDEO PROCESSOR & ACCESSORIES | Vision-Sciences, Inc. | Aug 3, 2009 | SESE |
| K091250 | DIAGNOSTIC CATHETER SYSTEM | Cardinal Health, Inc. | May 22, 2009 | SESE |
| K090853 | YIELD TISSUE SAMPLER | Broncus Technologies, Inc. | Apr 7, 2009 | SESE |
| K082720 | TRACHEAL INTUBATION FIBERVIDEOSCOPE, MODELS LF-Y0004 AND LF-Y0005 | Olympus Medical Systems Corporation | Nov 5, 2008 | SESE |
| K081518 | ULTRASOUND VIDEO BRONCHOSCOPE, MODEL EB-1970UK | Pentax Medical Company | Sep 5, 2008 | SESE |
| K071530 | KARL STORZ VIDEO FLEXIBLE VIDEO ENT ENDOSCOPE SYSTEM | KARL STORZ Endoscopy-America, Inc. | Aug 24, 2007 | SESE |
| K071473 | MODIFICATION TO SUPERDIMENSION/BRONCHUS PREMIUM 2 | Superdimension, Ltd. | Jul 12, 2007 | SESE |
| K061313 | EVIS EXERA 180 SYSTEM | Olympus Medical Systems Corporation | Aug 31, 2006 | SESE |
| K060243 | OLYMPUS GUIDE SHEATH, MODEL XBO1-836-13 | Olympus Medical Systems Corporation | Jun 23, 2006 | SESE |
| K050907 | FUJINON G5 BRONCHOSCOPES, MODELS EB-470S, EB-250S, AND EB-270P | Fujinon, Inc. | May 19, 2005 | SESE |
| K050220 | EVIS EXERA BRONCHOVIDEOSCOPE, OLYMPUS XBF-160Y3AC, XBF-1T160Y3AC,XBF-Q160Y2AC | Olympus Medical Systems Corporation | Feb 10, 2005 | SESE |
| K040940 | BRONCHOVIDEOSCOPE OLYMPUS XBF-D160HM | Olympus Corporation | Apr 19, 2004 | SESE |
| K040018 | EXCELON TRANSBRONCHIAL ASPIRATION NEEDLE, MODELS 6410, 6411, 6412 | Boston Scientific Corp | Jan 20, 2004 | SESE |
| K033225 | EVIS EXERA BRONCHOFIBERVIDEOSCOPE OLYMPUS BF TYPE XP160F, ITS ACCESSORIES AND ANCILLARY EQUIPMENT | Olympus Optical Co., Ltd. | Oct 16, 2003 | SESE |
| K031966 | ENK FIBEROPTIC ATOMIZER SET | Cook, Inc. | Oct 16, 2003 | SESU |
| K022446 | MUCUS COLLECTION PROBE, MODELS BC-401C & BC-402C | Aomori Olympus Co., Ltd. | Mar 28, 2003 | SESE |
| K023984 | MODIFICATION TO OLYMPUS BRONCHOSCOPES BF-40 SERIES, BF-240 SERIES, AND BF-160 SERIES | The Olympus Optical Co. | Jan 31, 2003 | SESE |
| K024165 | DUAL-LUMEN CATHETER | Bistech, Inc. | Jan 10, 2003 | SESE |
| K023376 | EB-1830T3, VIDEO BRONCHOSCOPE | Pentax Precision Instrument Corp. | Oct 16, 2002 | SESE |
| K022546 | HORIZONS ANSO TRANSBRONCHIAL ASPIRATION NEEDLES | Horizons Intl. Corp. | Aug 12, 2002 | SESE |
| K021344 | B-F200 BRONCHOSCOPE WITH BSS-F21 ENDOSHEATH SYSTEM | Vision-Sciences, Inc. | May 24, 2002 | SESE |
| K013731 | GIMMI ALPHA SINUSCOPES MODEL # E.8282.01/31/71 + E.8284.01/31/71; GIMMI ALPHA BRONCHOSCOPES MODEL # E.8189.00/01/02/03 | Gimmi GmbH | Nov 27, 2001 | SESE |
| K013111 | EXHALE PROBE | Broncus Technologies, Inc. | Oct 1, 2001 | SESE |
| K012073 | OLYMPUS SPRAY CATHETER PW-6C-1 | The Olympus Optical Co. | Aug 10, 2001 | SESE |
| K011267 | EXHALE RF PROBE | Broncus Technologies, Inc. | May 8, 2001 | SESE |
| K993900 | COAGULATION ELECTRODE, MODEL 2000; RADIOFREQUENCY GENERATOR, MODEL 20-115 | Broncus Technologies, Inc. | Jan 28, 2000 | SESE |
| K990547 | PILLING WECK SURGICAL Y STENT FORCEPS | Pilling Weck, Inc. | Apr 27, 1999 | SESE |
| K983878 | CZAJA-MCCAFFREY RIGID STENT INTRODUCER/ENDOSCOPE | E. Benson Hood Laboratories, Inc. | Jan 29, 1999 | SESE |
| K984157 | MODIFICATION TO WILSON-COOK LUNG BIOPSY NEEDLE | Wilson-Cook Medical, Inc. | Dec 8, 1998 | SESE |
| K983124 | MILL-ROSE LABORATORIES TRANSBRONCHIAL NEEDLE ASPIRATION (TBNA) CYTOLOGY PROCEDURAL KIT | Mill-Rose Laboratory | Oct 30, 1998 | SESE |
| K983122 | MILL-ROSE LABORATORIES TRANSBRONCHIAL NEEDLE ASPIRATION (TBNA) COMBINATION CYTOLOGY/HISTOLOGY PROCEDURAL KIT | Mill-Rose Laboratory | Oct 30, 1998 | SESE |
| K982983 | LSVP INTERNATIONAL BIOPSY FORCEPS | Lsvp Intl., Inc. | Sep 29, 1998 | SESE |
| K981543 | OLYMPUS LF-TP AND LF-DP TRACHEAL INTUBATION FIBERSCOPES, ACCESSORIES AND ANCILLARY EQUIPMENT | The Olympus Optical Co. | Jun 8, 1998 | SESE |
| K980046 | BRONCHIAL CATHETER SYSTEM | Broncus Technologies, Inc. | May 1, 1998 | SESE |
| K974642 | COMBICATH CATHETER | Plastimed Laboratoire Pharmaceutique | Mar 13, 1998 | SESE |
| K970107 | INTUBATION ENDOSCOPE AND INTRODUCER SHEATH | Urohealth Systems, Inc. | Nov 18, 1997 | SESE |
| K963795 | VISION-SCIENCES MODEL B-F100 BRONCHOSCOPE WITH MODEL BS-F21 DISPOSABLE ENDOSHEATH | Vision-Sciences, Inc. | Dec 23, 1996 | SESE |
| K963252 | TBAN | Boston Scientific Corp | Sep 20, 1996 | SESE |
| K963033 | BF 240/P240/IT240 BRONCHOVIDEOSCOPE & ACCESSORIES | Olympus America, Inc. | Sep 9, 1996 | SESE |
| K962901 | OLYMPUS B5-2C/B7-2C BALLOON CATHETER | Olympus America, Inc. | Aug 20, 1996 | SESE |
| K962485 | OLYMPUS FG SERIES OF RAT TOOTH GRASPING FORCEPS (ENT) | Olympus America, Inc. | Aug 20, 1996 | SESE |
| K962533 | OLYPUS FG SERIES GRASPING FORCEPS | Olympus America, Inc. | Aug 9, 1996 | SESE |
| K962380 | OLYMPUS BF TYPE 200 VIDEO BRONCHSCOPES(BF-200/BF-P200/BF-IT200) | Olympus America, Inc. | Aug 9, 1996 | SESE |
| K962367 | OLYMPUS BASKET GRASPERS | Olympus America, Inc. | Aug 5, 1996 | SESE |
| K962378 | OLYMPUS FG-45/46-1 GRASPING FORCEPS | Olympus America, Inc. | Aug 2, 1996 | SESE |
| K962555 | OLYMPUS FB SERIES BIOPSY FORCEPS | Olympus America, Inc. | Jul 30, 1996 | SESE |
| K962736 | MILL-ROSE LARYNGOSCOPIC INJECTION NEEDLE | Mill-Rose Laboratory | Jul 29, 1996 | SESE |
| K961178 | KARL STORZ INTUBATION FIBERSCOPE | KARL STORZ Endoscopy-America, Inc. | May 14, 1996 | SESE |
| K960880 | MILL-ROSE BLIND MICROBIOLOGY BRUSH | Mill-Rose Laboratory | Apr 29, 1996 | SESE |
| K960791 | KARL STORZ HUZLY HIGH-FREQUENCY CUTTING LOOPS | KARL STORZ Endoscopy-America, Inc. | Mar 11, 1996 | SESE |
| K954797 | KARL STORZ RHINO-LARYNGO-BRONCHO FIBERSCOPE, FIBERSCOPE FOR BRONCHOSCOPY | KARL STORZ Endoscopy-America, Inc. | Jan 17, 1996 | SESE |
| K945268 | OPTUS BRONCHOSCOPES | Optus, Inc. | Dec 21, 1995 | SESE |
| K954707 | BRONCHOSCOPE | Fujinon, Inc. | Nov 22, 1995 | SESE |
| K954125 | SAUER ENDOSCOPE GUIDE AND INTUBATION AID | KARL STORZ Endoscopy-America, Inc. | Oct 6, 1995 | SESE |
| K953596 | DISTENDING DIVERTICULOSCOPE | KARL STORZ Endoscopy-America, Inc. | Sep 26, 1995 | SESE |
| K950925 | JEDMED LARYNGEAL SCOPE | Jedmed Instrument Co. | Aug 11, 1995 | SESE |
| K952081 | KARL STORZ CATHETERS, ADAPTORS, SUCTION/IRRIGATION CATHETERS, TUBING | KARL STORZ Endoscopy-America, Inc. | Jul 3, 1995 | SESE |
| K951826 | KARL STORZ TRACHEAL HIGH FREQUENCY RESECTOSCOPE | KARL STORZ Endoscopy-America, Inc. | May 15, 1995 | SESE |
| K951199 | FB-18X, FIBER BRONCHOSCOPE | Pentax Precision Instrument Corp. | Apr 10, 1995 | SESE |
| K950965 | KARL STORZ STENT APPLICATOR FORCEPS | KARL STORZ Endoscopy-America, Inc. | Mar 31, 1995 | SESE |
| K951051 | RITE-BITE BIOPSY FORCEPS | Mill-Rose Laboratory | Mar 24, 1995 | SESE |
| K950786 | OLYMPUS BIOPSY FORCEPS MODEL FB-44 | Olympus America, Inc. | Mar 6, 1995 | SESE |
| K950636 | OLYMPUS DISPOSABLE BIOPSY FORCEPS | Olympus America, Inc. | Feb 27, 1995 | SESE |
| K931442 | 11274 AB FLEXIBLE PEDIATRIC BRONCHOSCOPE | KARL STORZ Endoscopy-America, Inc. | Jan 24, 1995 | SESE |
| K944976 | BRONCHOSCOPE,NON-RIGID | Citation Medical Corp. | Dec 21, 1994 | SESE |
| K944649 | MILL-ROSE HARRELL BRONCHIAL BRUSH | Mill-Rose Laboratory | Nov 30, 1994 | SESE |
| K944650 | WANG BRONCHIAL NEEDLE BRUSH | Mill-Rose Laboratory | Nov 22, 1994 | SESE |
| K943700 | KARL STORZ BRONCHOSCOPE ACCESSORIES | KARL STORZ Endoscopy-America, Inc. | Aug 23, 1994 | SESE |
| K942388 | TAS-(VARIOUS) ULTRATHIN FLEXIBLE ENDOSCOPE | Technology Marketing Group | Aug 17, 1994 | SESE |
| K941264 | RICHARD ROD LENS LARYNGOSCOPE | Smith & Nephew Richards, Inc. | Jul 18, 1994 | SESE |
| K941161 | FLEXIBLE GRASPING FORCEPS | Surgical Technologies, Inc. | May 4, 1994 | SESE |
| K940521 | MILL-ROSE PROTECTED TRANSLARYNGOSCOPIC CATHETER | Mill-Rose Laboratory | May 4, 1994 | SESE |
| K941158 | FLEXIBLE BIOPSY CUP FORCEPS | Surgical Technologies, Inc. | Apr 28, 1994 | SESE |
| K934920 | VB-1830/VB-1530, VIDEO BRONCHOSCOPE | Pentax Precision Instrument Corp. | Jan 26, 1994 | SESE |
| K933433 | MODIFIED BRONCHOSCOPE AND ACCESSORIES | Fujinon, Inc. | Nov 1, 1993 | SESE |
| K931154 | EVIS 200 SYSTEM | Olympus Corp. | Oct 7, 1993 | SESE |
| K922204 | MILL-ROSE PULMONARY FORCEPS | Mill-Rose Laboratory | Jul 13, 1993 | SESE |
| K926430 | CANNULATED BIOPSY FORCEPS | Thomasville Medical Assoc. | Mar 26, 1993 | SESE |
Top Applicants
- KARL STORZ Endoscopy-America, Inc. — 12 clearances
- Olympus Medical Systems Corp. — 11 clearances
- Mill-Rose Laboratory — 11 clearances
- Olympus America, Inc. — 10 clearances
- Intuitive Surgical, Inc. — 10 clearances
