Product Code: EOQ
FDA class 2
21 CFR 874.4680
Bronchoscope (Flexible Or Rigid)
Ear, Nose, Throat
The bronchoscope (flexible or rigid) is a tubular endoscopic device with a group of accessory devices that attach to it, intended to examine or treat the larynx and tracheobronchial tree. It is classified as FDA Class 2, meaning it poses moderate risk and requires 510(k) premarket clearance. The product code is EOQ, regulated under 21 CFR 874.4680 in the Ear, Nose, Throat specialty. If the device is reprocessed, reprocessing validation data must be included in a 510(k) submission; if reusable, validated reprocessing instructions are also required.
510(k)s
239
FEI Numbers
163
Registration Numbers
163
Unique Applicants
101
Years Active
50
Research product code EOQ in seconds
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Basic Information
- Product Code
- EOQ
- Device Class
- FDA class 2
- Regulation Number
- 874.4680
- Medical Specialty
- Ear, Nose, Throat
- Review Panel
- EN
- Submission Type
- 1
Device Characteristics
✗
GMP Exempt
✗
Implant
✗
Life Sustain/Support
✗
Third Party
—
Summary Malfunction Reporting
Definition
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. If the device is reprocessed, reprocessing validation data for this device type must be included in a 510(k) submission. If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
510(k) Clearance History
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Related 510(k) Clearances
This FDA classification is associated with 239 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K253137 | FUJIFILM Endoscope Model EB-840S; FUJIFILM Endoscope Model EB-840T | Jun 16, 2026 | Substantially Equivalent | Fujifilm Corporation |
| K260565 | SmartClip Delivery Catheter (ADR-1715) | May 14, 2026 | Substantially Equivalent | Elucent Medical |
| K252341 | EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-Q190); EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-H190 ); EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-1TH190) | Apr 23, 2026 | Substantially Equivalent | Olympus Medical Systems Corp. |
| K260420 | LoopView® Single-Use Digital Flexible Bronchoscope (B27-C, B27-CG) | Apr 08, 2026 | Substantially Equivalent | MacroLux Medical Technology Co., Ltd. |
| K250863 | FUJIFILM Ultrasonic Endoscope EB-710US | Dec 12, 2025 | Substantially Equivalent | Fujifilm Corporation |
| K251731 | KARL STORZ Flexible Intubation Video Endoscope Sterile (FIVE-S) (0916612) | Dec 05, 2025 | Substantially Equivalent | Karl Storz SE & CO. KG |
| K252045 | Ion Endoluminal System (IF1000) | Sep 23, 2025 | Substantially Equivalent | Intuitive Surgical, Inc. |
| K251894 | Himaging Bronchscope System | Sep 23, 2025 | Substantially Equivalent | Himaging Technology (Shanghai) Co., Ltd. |
| K252528 | Ion Endoluminal System (IF1000) | Sep 05, 2025 | Substantially Equivalent | Intuitive Surgical, Inc. |
| K251752 | Flexible Bronchoscope (BS27U-12EU, BS27U-12US, BS38U-20EU, BS38U-20US) | Aug 27, 2025 | Substantially Equivalent | Shanghai AnQing Medical Instrument Co., Ltd. |
| 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) | Aug 11, 2025 | Substantially Equivalent | Zhejiang UE Medical Corp. |
| K250232 | Vathin® Video Bronchoscope System | Jul 25, 2025 | Substantially Equivalent | Hunan Vathin Medical Instrument Co., Ltd. |
| 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) | Jun 23, 2025 | Substantially Equivalent | Olympus Medical Systems Corp. |
| K244017 | FUJIFILM Endoscope Model EB-710P; FUJIFILM Processor EP-8000 | Jun 13, 2025 | Substantially Equivalent | Fujifilm Corporation |
| K250118 | Disposable Balloon Catheter B5-2C | Jun 04, 2025 | Substantially Equivalent | Olympus Medical Systems Corporation |
| K250957 | Disposable Biopsy Forceps (FB-211D); Disposable Biopsy Forceps (FB-221D); Disposable Biopsy Forceps (FB-231D); Disposable Biopsy Forceps (FB-241D) | May 30, 2025 | Substantially Equivalent | Olympus Medical Systems Corporation |
| 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 | May 29, 2025 | Substantially Equivalent | Shanghai AnQing Medical Instrument Co., Ltd. |
| 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. | May 28, 2025 | Substantially Equivalent | Shenzhen Insighters Medical Technology Co., Ltd. |
| K243541 | LumiRex Bronchoscope | Apr 30, 2025 | Substantially Equivalent | Contra Healthcare Solutions, LLC |
| 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)) | Mar 19, 2025 | Substantially Equivalent | Scivita Medical Technology Co., Ltd. |
| 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) | Mar 14, 2025 | Substantially Equivalent | Shenzhen Sanping Image Technology Co., Ltd. |
| K242324 | DUTAU-NOVATECH® | Feb 06, 2025 | Substantially Equivalent | Novatech SA |
| K243219 | MONARCH Platform (MON-000008) | Jan 23, 2025 | Substantially Equivalent | Auris Health, Inc. |
| 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 | Jan 16, 2025 | Substantially Equivalent | Hunan Vathin Medical Instrument Co., Ltd. |
| 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) | Oct 29, 2024 | Substantially Equivalent | Hunan Vathin Medical Instrument Co., Ltd. |
| K240289 | Full HD Endoscopic Image Processor (HDVS-S200A, HDVS-S200B, HDVS-S200C, HDVS-S200D) | Oct 23, 2024 | Substantially Equivalent | Scivita Medical Technology Co., Ltd. |
| K242070 | Ion Endoluminal System (IF 1000) | Sep 24, 2024 | Substantially Equivalent | Intuitive Surgical, Inc. |
| K232601 | BroncTru Transbronchial Access Tool | May 31, 2024 | Substantially Equivalent | Broncus Medical, Inc. |
| K234113 | MiiS Horus Bronchoscope; MiiS Horus Endoscope Display System -Tablet; MiiS Horus Endoscope Display System -Video Box | May 01, 2024 | Substantially Equivalent | Medimaging Integrated Solution, Inc (Miis) |
| K232038 | BioStar Single Use Transbronchial Aspiration Needle | Apr 26, 2024 | Substantially Equivalent | Broncus Medical, Inc. |
| K233779 | LoopView® Single-Use Digital Flexible Bronchoscope (B38, B38-C, B50, B50-C, B58, B58-C), ViewHub® Video Processor (S13) | Apr 05, 2024 | Substantially Equivalent | MacroLux Medical Technology Co., Ltd. |
| K240135 | Ion Endoluminal System (Ion Fully Articulating Catheter) (IF1000) | Apr 03, 2024 | Substantially Equivalent | Intuitive Surgical, Inc. |
| K231107 | Bronchoscope System | Feb 15, 2024 | Substantially Equivalent | Hunan Endoso Life Technology Co., Ltd. |
| K240075 | FUJIFILM Endoscope Model EB-710XT | Feb 07, 2024 | Substantially Equivalent | FUJIFILM Healthcare Americas Corporation |
| 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 | Jan 18, 2024 | Substantially Equivalent | Pentax of America, Inc. |
| 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 | Jan 12, 2024 | Substantially Equivalent | Pentax of America, Inc. |
| K233671 | Ambu® aScope 5 Broncho 4.2/2.2; Ambu® aScope 5 Broncho 2.7/1.2; Ambu® aView 2 Advance | Jan 04, 2024 | Substantially Equivalent | Ambu A/S |
| K232984 | Ion Endoluminal System (IF1000) | Dec 18, 2023 | Substantially Equivalent | Intuitive Surgical, Inc. |
| K231521 | Broncho Videoscope System | Nov 14, 2023 | Substantially Equivalent | Scivita Medical Technology Co., Ltd. |
| K232582 | Ambu® aScope 5 Broncho 4.2/2.2 Sampler Set | Sep 20, 2023 | Substantially Equivalent | Ambu A/S |
| K230428 | Ambu® aScope 5 Broncho 2.7/1.2, Ambu® aScope 5 Broncho 4.2/2.2, Ambu® aBox 2 | Aug 10, 2023 | Substantially Equivalent | Ambu A/S |
| K222861 | EVIS XI Video System Center Olympus CV-1500, Bronchovideoscope Olympus BF-H1100, Bronchovideoscope Olympus BF-1TH1100 | Jun 15, 2023 | Substantially Equivalent | Olympus Medical Systems Corporation |
| K223299 | Ambu® aScope 5 Broncho HD 5.0/2.2, Ambu® aScope 5 Broncho HD 5.6/2.8, Ambu® aView 2 Advance | Jun 01, 2023 | Substantially Equivalent | Ambu A/S |
| K223836 | Vathin® Video Bronchoscope System | May 15, 2023 | Substantially Equivalent | Hunan Vathin Medical Instrument Co., Ltd. |
| K230948 | BFlex 2 Slim 3.8 Single-Use Bronchoscope | May 03, 2023 | Substantially Equivalent | Verathon Medical (Canada) Ulc |
| K222910 | Bronchoscope System | Apr 11, 2023 | Substantially Equivalent | Shenzhen HugeMed Medical Technical Development Co., Ltd. |
| K221340 | iNod Ultrasound Guided Biopsy Needle (UPN: M00502060), iNod Ultrasound Guidance Console (UPN: M00503210) | Mar 02, 2023 | Substantially Equivalent | Boston Scientific Corporation |
| K223144 | Galaxy System | Mar 01, 2023 | Substantially Equivalent | Noah Medical Corp. |
| K223782 | Ambu aScope 5 Broncho HD 5.6/2.8 Sampler Set, Ambu aScope 5 Broncho HD 5.0/2.2 Sampler Set | Jan 12, 2023 | Substantially Equivalent | Ambu A/S |
| K213235 | PENTAX Medical ONE Pulmo Single Use Video Bronchoscope System | Dec 21, 2022 | Substantially Equivalent | Pentax of America, Inc. |
| K220957 | FUJIFILM Endoscope Model EB-710P | Nov 10, 2022 | Substantially Equivalent | Fujifilm Corporaton |
| K221631 | Tracheal Intubation Fiberscope OLYMPUS LF-P, VISERA Tracheal Intubation Videoscope OLYMPUS LF Type V | Sep 26, 2022 | Substantially Equivalent | Olympus Medical Systems Corp. |
| K221302 | Recon Steerable Sheath | Aug 15, 2022 | Substantially Equivalent | Serpex Medical, Inc. |
| K222014 | EXALT Model B Single-Use Bronchoscope | Jul 28, 2022 | Substantially Equivalent | Boston Scientific Corporation |
| K220606 | Ambu aScope 5 Broncho HD 5.6/2.8, Ambu aScope 5 Broncho HD 5.0/2.2, Ambu aBox 2 | Jul 25, 2022 | Substantially Equivalent | Ambu A/S |
| K213782 | Single-Use Video Bronchoscopes, Digital Controller | Jul 08, 2022 | Substantially Equivalent | Micro-Tech (Nanjing) Co., Lts |
| K220399 | WiScope Digital Bronchoscope System, WiScope Single-Use Digital Flexible Bronchoscope, WiScope Image System | Jun 16, 2022 | Substantially Equivalent | OTU Medical, Inc. |
| K220299 | Ion Endoluminal System (IF1000) | Jun 16, 2022 | Substantially Equivalent | Intuitive Surgical, Inc. |
| K213635 | Vathin Video Bronchoscope System | Feb 28, 2022 | Substantially Equivalent | Hunan Vathin Medical Instrument Co., Ltd. |
| K212886 | Broncoflex Agile, Broncoflex Vortex, Screeni | Feb 16, 2022 | Substantially Equivalent | Axess Vision Technology |
| K212656 | Flexible Intubation Video Endoscope Sterile (FIVE-S) | Dec 29, 2021 | Substantially Equivalent | Karl Storz Endoscopy America |
| K211169 | Bronchoscope System | Nov 24, 2021 | Substantially Equivalent | Shanghai AnQing Medical Instrument Co., Ltd. |
| K211947 | GlideScope BFlex 2.8 Single-Use Bronchoscope | Nov 03, 2021 | Substantially Equivalent | Verathon Medical (Canada) Ulc |
| K210928 | PENTAX Medical Video Bronchoscope EB11-J10 | Oct 21, 2021 | Substantially Equivalent | Pentax of America, Inc. |
| K212667 | Single Use Guide Sheath Kit-401, K-402 | Sep 22, 2021 | Substantially Equivalent | Olympus Medical Systems Corp. |
| K212048 | Ion Endoluminal System (Ion Fully Articulating Catheter), Ion Endoluminal System (Ion Peripheral Vision Probe) | Aug 26, 2021 | Substantially Equivalent | Intuitive Surgical, Inc. |
| K211030 | EXALT Model B Single-Use Bronchoscope (Slim), EXALT Model B Single-Use Bronchoscope (Regular), EXALT Model B Single-Use Bronchoscope (Large), EXALT Monitor | Aug 09, 2021 | Substantially Equivalent | Boston Scientific Corporation |
| K210379 | Broncho Videoscope System | Jul 28, 2021 | Substantially Equivalent | Scivita Medical Technology Co., Ltd. |
| K211493 | Monarch Platform | Jul 09, 2021 | Substantially Equivalent | Auris Health, Inc. |
| K210883 | aScope 4 Broncho Regular Sampler Set 5.0/2.2, aScope 4 Broncho Large Sampler Set 5.8/2.8 | Jun 17, 2021 | Substantially Equivalent | Ambu A/S |
| K202987 | Rescue Pulmonary Grasping Forceps | Apr 29, 2021 | Substantially Equivalent | Anrei Medical (Hangzhou) Co., Ltd. |
| K202346 | SPiN Vision Video Bronchoscope System | Feb 19, 2021 | Substantially Equivalent | Veran Medical Technologies, Inc. |
| K201300 | Airway Mobilescope | Jan 26, 2021 | Substantially Equivalent | Olympus Medical Systems Corp. |
| K201758 | EVIS EXERA III Bronchovideoscope Olympus BF-XP190, EVIS EXERA III Bronchovideoscope Olympus BF-P190 | Jan 21, 2021 | Substantially Equivalent | Olympus Medical Systems Corp. |
| K200702 | EasyPath RF Introducer Sheath | Jan 14, 2021 | Substantially Equivalent | Broncus Medical, Inc. |
| 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 | Dec 17, 2020 | Substantially Equivalent | Olympus Medical Systems Corp. |
| K202370 | Ion Endoluminal System | Nov 16, 2020 | Substantially Equivalent | Intuitive Surgical, Inc. |
| K202180 | Broncoflex Agile; Product Reference: 20030001 , Broncoflex Vortex; Product Reference: 10030001, Screeni; Product Reference: 30030001 | Oct 22, 2020 | Substantially Equivalent | Axess Vision Technology |
| K200678 | PENTAX Medical Video Bronchoscope EB-J10 Series | Jul 30, 2020 | Substantially Equivalent | Pentax of America, Inc. |
| K201146 | Ion Endoluminal System | Jun 26, 2020 | Substantially Equivalent | Intuitive Surgical, Inc. |
| K200397 | Single Use Biopsy Forceps FB-456D | Apr 24, 2020 | Substantially Equivalent | Olympus Medical Systems Corp. |
| K193534 | Monarch Platform | Apr 15, 2020 | Substantially Equivalent | Auris Health, Inc. |
| K192164 | Single Use Guide Sheath Kit K-401, K-402, & Single Use Guiding Device CC-220DR | Mar 06, 2020 | Substantially Equivalent | Olympus Medical Systems Corp. |
| K191828 | Vathin Video Bronchoscope System | Feb 13, 2020 | Substantially Equivalent | Hunan Vathin Medical Instrument Co., Ltd. |
| K193488 | GlideScope BFlex 3.8 Single-Use Bronchoscope | Jan 16, 2020 | Substantially Equivalent | Verathon Medical (Canada) Ulc |
| K192367 | Ion Endoluminal System | Nov 26, 2019 | Substantially Equivalent | Intuitive Surgical, Inc. |
| K183516 | PENTAX Medical Ultrasound Video Bronchoscope EB19-J10U | Sep 06, 2019 | Substantially Equivalent | Pentax of America, Inc. |
| K183419 | EVIS EXERA III Bronchovideoscope Olympus BF-XT190 | Sep 05, 2019 | Substantially Equivalent | Olympus Medical Systems Corp. |
| K183607 | FUJIFILM Bronchoscope | Aug 23, 2019 | Substantially Equivalent | Fujifilm Corporation |
| K191948 | GlideScope BFlex 5.8 Single-Use Bronchoscope | Aug 21, 2019 | Substantially Equivalent | Verathon Medical (Canada) Ulc |
| K183654 | PENTAX Medical EB-1970UK Ultrasound Video Bronchoscope + Hitachi NOBLUS and HI VISION Preirus | May 23, 2019 | Substantially Equivalent | Pentax of America, Inc. |
| K182253 | FUJIFILM Video Bronchoscopes | Apr 04, 2019 | Substantially Equivalent | Fujifilm Corporation |
| K183085 | CoreDx Pulmonary Mini-Forceps | Mar 08, 2019 | Substantially Equivalent | Boston Scientific Corporation |
| K182825 | FUJIFILM Ultrasonic Endoscope | Feb 22, 2019 | Substantially Equivalent | Fujifilm Corporation |
| K182188 | Ion Endoluminal System ; Flexision Biopsy Needle | Feb 14, 2019 | Substantially Equivalent | Intuitive Surgical |
| K183256 | GlideScope BFlex Single-Use Bronchoscope System | Jan 04, 2019 | Substantially Equivalent | Verathon Medical (Canada) Ulc |
| K172726 | EVIS EXERA III BRONCHOFIBERVIDEOSCOPE OLYMPUS BF-MP190F, Single Use Biopsy Forceps FB-433D | Apr 30, 2018 | Substantially Equivalent | Olympus Medical Systems Corp. |
| K172955 | LungVision Tool | Apr 26, 2018 | Substantially Equivalent | Bodyvision Medical , Ltd. |
| 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 | Mar 28, 2018 | Substantially Equivalent | Ambu A/S |
| K173760 | Monarch Endoscopy Platform (Monarch Platform) | Mar 22, 2018 | Substantially Equivalent | Auris Surgical Robotics, Inc. |
| K163377 | Captura Disposable Bronchoscope Biopsy Forceps | Feb 21, 2018 | Substantially Equivalent | Wilson-Cook Medical, Inc. |
| K173554 | PENTAX Medical Video Bronchoscopes, PENTAX Medical Video Naso-Pharyngo-Laryngoscope, and PENTAX Medical Ultrasond Video Bronchoscope | Jan 19, 2018 | Substantially Equivalent | Pentax of America, Inc. |
| K171291 | FUJIFILM Bronchoscope Model EB-530P | Jan 19, 2018 | Substantially Equivalent | Fujifilm Medical Systems U.S.A, Inc. |
| K171492 | B7 2C Occlusion Balloon | Nov 20, 2017 | Substantially Equivalent | Spiration, Inc. |
| K163537 | Arcpoint pulmonary needle - 18 ga, Arcpoint pulmonary needle - 21 ga | Apr 21, 2017 | Substantially Equivalent | Covidien, LLC |
| K163248 | Expect Pulmonary Endobronchial Ultrasound Transbronchial Aspiration Needle | Mar 27, 2017 | Substantially Equivalent | Boston Scientific Corporation |
| K162611 | PeriFLEX | Feb 09, 2017 | Substantially Equivalent | Spiration, Inc. |
| 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 | Sep 01, 2016 | Substantially Equivalent | Ambu A/S |
| K152319 | Auris Robotic Endoscopy System (ARES) | May 26, 2016 | Substantially Equivalent | Auris Surgical Robotics, Inc. |
| K152466 | Neo-Bronchoscope -Digital Video Bronchoscopy System(Rigid/Flexible) | May 19, 2016 | Substantially Equivalent | Prosurg, Inc. |
| K151315 | Expect Pulmonary Endobronchial Ultrasound Transbronchial Aspiration Needle | Nov 10, 2015 | Substantially Equivalent | Boston Scientific Corporation |
| K143727 | PENTAX Medical EKP-i5010 Video Processor with EB Family | Oct 29, 2015 | Substantially Equivalent | Pentax of America, Inc. |
| K142934 | CrossCountry Transbronchial Access Tool straight, CrossCountry Transbronchial Access Tool curved | Jun 17, 2015 | Substantially Equivalent | Covidien |
| K150280 | PulmoVia Working Channel | Jun 11, 2015 | Substantially Equivalent | Sanovas, Inc. |
| K142839 | GenCut Core Biopsy System | Apr 29, 2015 | Substantially Equivalent | Covidien, LLC |
| K142909 | Flexible 19G EBUS Needle | Apr 24, 2015 | Substantially Equivalent | Spiration, Inc. |
| K141366 | VIDEO BRONCHOSCOPE SYSTEM | Dec 17, 2014 | Substantially Equivalent | Scholly Fiberoptic GmbH |
| K131946 | ENTAX ULTRASOUND VIDEO BRONCHOSCOPE EB-1970UK + HI VISIN PREIRUS | Apr 25, 2014 | Substantially Equivalent | Pentax Medical Company |
| K131028 | PENTAX VIDEO BRONCHOSCOPES (EB FAMILY) | Apr 10, 2014 | Substantially Equivalent | Pentax Medical Company |
| K130845 | AMBU ASCOPE 3 5.0/2.2; AMBU ASCOPE 3 SLIM 3.8/1.2; AMBU AVIEW | Nov 01, 2013 | Substantially Equivalent | Ambu A/S |
| K131234 | LUNGPOINT TOOLS (LUNGPOINT SHEATH, LUNGPOINT DILATION BALLOON) | Oct 15, 2013 | Substantially Equivalent | Broncus Medical, Inc. |
| K131401 | BLOWFISH TRANSBRONCHIAL MICRO-INFUSION CATHETER | Jul 02, 2013 | Substantially Equivalent | Mercator Medsystems, Inc. |
| K121959 | EVIS EXERA III VIDEO SYSTEM | Jan 10, 2013 | Substantially Equivalent | Olympus Medical Systems Corp. |
| K122535 | FUJINON/FUJIFILM EB-530 SERIES BRONCHOSCOPES (EB-530S, EB-530T AND EB-530H | Dec 13, 2012 | Substantially Equivalent | Fujifilm Medical System U.S.A., Inc. |
| K121035 | FUJINON/FUJIFILM ULTRASONIC ENDOSCOPE EB-530US | Jun 04, 2012 | Substantially Equivalent | Fujifilm Medical System U.S.A., Inc. |
| K091768 | VIDEO SCIENCES BRS-5000 VIDEO BRONCHOSCOPE WITH ENDOSHEATH SYSTEM, DPU-5000/DPU-5050 VIDEO PROCESSOR & ACCESSORIES | Aug 03, 2009 | Substantially Equivalent | Vision-Sciences, Inc. |
| K091250 | DIAGNOSTIC CATHETER SYSTEM | May 22, 2009 | Substantially Equivalent | Cardinal Health, Inc. |
| K090853 | YIELD TISSUE SAMPLER | Apr 07, 2009 | Substantially Equivalent | Broncus Technologies, Inc. |
| K082720 | TRACHEAL INTUBATION FIBERVIDEOSCOPE, MODELS LF-Y0004 AND LF-Y0005 | Nov 05, 2008 | Substantially Equivalent | Olympus Medical Systems Corporation |
| K081518 | ULTRASOUND VIDEO BRONCHOSCOPE, MODEL EB-1970UK | Sep 05, 2008 | Substantially Equivalent | Pentax Medical Company |
| K071530 | KARL STORZ VIDEO FLEXIBLE VIDEO ENT ENDOSCOPE SYSTEM | Aug 24, 2007 | Substantially Equivalent | KARL STORZ Endoscopy-America, Inc. |
| K071473 | MODIFICATION TO SUPERDIMENSION/BRONCHUS PREMIUM 2 | Jul 12, 2007 | Substantially Equivalent | Superdimension, Ltd. |
| K061313 | EVIS EXERA 180 SYSTEM | Aug 31, 2006 | Substantially Equivalent | Olympus Medical Systems Corporation |
| K060243 | OLYMPUS GUIDE SHEATH, MODEL XBO1-836-13 | Jun 23, 2006 | Substantially Equivalent | Olympus Medical Systems Corporation |
| K050907 | FUJINON G5 BRONCHOSCOPES, MODELS EB-470S, EB-250S, AND EB-270P | May 19, 2005 | Substantially Equivalent | Fujinon, Inc. |
| K050220 | EVIS EXERA BRONCHOVIDEOSCOPE, OLYMPUS XBF-160Y3AC, XBF-1T160Y3AC,XBF-Q160Y2AC | Feb 10, 2005 | Substantially Equivalent | Olympus Medical Systems Corporation |
| K040940 | BRONCHOVIDEOSCOPE OLYMPUS XBF-D160HM | Apr 19, 2004 | Substantially Equivalent | Olympus Corporation |
| K040018 | EXCELON TRANSBRONCHIAL ASPIRATION NEEDLE, MODELS 6410, 6411, 6412 | Jan 20, 2004 | Substantially Equivalent | Boston Scientific Corp |
| K033225 | EVIS EXERA BRONCHOFIBERVIDEOSCOPE OLYMPUS BF TYPE XP160F, ITS ACCESSORIES AND ANCILLARY EQUIPMENT | Oct 16, 2003 | Substantially Equivalent | Olympus Optical Co., Ltd. |
| K031966 | ENK FIBEROPTIC ATOMIZER SET | Oct 16, 2003 | Unknown | Cook, Inc. |
| K022446 | MUCUS COLLECTION PROBE, MODELS BC-401C & BC-402C | Mar 28, 2003 | Substantially Equivalent | Aomori Olympus Co., Ltd. |
| K023984 | MODIFICATION TO OLYMPUS BRONCHOSCOPES BF-40 SERIES, BF-240 SERIES, AND BF-160 SERIES | Jan 31, 2003 | Substantially Equivalent | The Olympus Optical Co. |
| K024165 | DUAL-LUMEN CATHETER | Jan 10, 2003 | Substantially Equivalent | Bistech, Inc. |
| K023376 | EB-1830T3, VIDEO BRONCHOSCOPE | Oct 16, 2002 | Substantially Equivalent | Pentax Precision Instrument Corp. |
| K022546 | HORIZONS ANSO TRANSBRONCHIAL ASPIRATION NEEDLES | Aug 12, 2002 | Substantially Equivalent | Horizons Intl. Corp. |
| K021344 | B-F200 BRONCHOSCOPE WITH BSS-F21 ENDOSHEATH SYSTEM | May 24, 2002 | Substantially Equivalent | Vision-Sciences, Inc. |
| 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 | Nov 27, 2001 | Substantially Equivalent | Gimmi GmbH |
| K013111 | EXHALE PROBE | Oct 01, 2001 | Substantially Equivalent | Broncus Technologies, Inc. |
| K012073 | OLYMPUS SPRAY CATHETER PW-6C-1 | Aug 10, 2001 | Substantially Equivalent | The Olympus Optical Co. |
| K011267 | EXHALE RF PROBE | May 08, 2001 | Substantially Equivalent | Broncus Technologies, Inc. |
| K993900 | COAGULATION ELECTRODE, MODEL 2000; RADIOFREQUENCY GENERATOR, MODEL 20-115 | Jan 28, 2000 | Substantially Equivalent | Broncus Technologies, Inc. |
| K990547 | PILLING WECK SURGICAL Y STENT FORCEPS | Apr 27, 1999 | Substantially Equivalent | Pilling Weck, Inc. |
| K983878 | CZAJA-MCCAFFREY RIGID STENT INTRODUCER/ENDOSCOPE | Jan 29, 1999 | Substantially Equivalent | E. Benson Hood Laboratories, Inc. |
| K984157 | MODIFICATION TO WILSON-COOK LUNG BIOPSY NEEDLE | Dec 08, 1998 | Substantially Equivalent | Wilson-Cook Medical, Inc. |
| K983124 | MILL-ROSE LABORATORIES TRANSBRONCHIAL NEEDLE ASPIRATION (TBNA) CYTOLOGY PROCEDURAL KIT | Oct 30, 1998 | Substantially Equivalent | Mill-Rose Laboratory |
| K983122 | MILL-ROSE LABORATORIES TRANSBRONCHIAL NEEDLE ASPIRATION (TBNA) COMBINATION CYTOLOGY/HISTOLOGY PROCEDURAL KIT | Oct 30, 1998 | Substantially Equivalent | Mill-Rose Laboratory |
| K982983 | LSVP INTERNATIONAL BIOPSY FORCEPS | Sep 29, 1998 | Substantially Equivalent | Lsvp Intl., Inc. |
| K981543 | OLYMPUS LF-TP AND LF-DP TRACHEAL INTUBATION FIBERSCOPES, ACCESSORIES AND ANCILLARY EQUIPMENT | Jun 08, 1998 | Substantially Equivalent | The Olympus Optical Co. |
| K980046 | BRONCHIAL CATHETER SYSTEM | May 01, 1998 | Substantially Equivalent | Broncus Technologies, Inc. |
| K974642 | COMBICATH CATHETER | Mar 13, 1998 | Substantially Equivalent | Plastimed Laboratoire Pharmaceutique |
| K970107 | INTUBATION ENDOSCOPE AND INTRODUCER SHEATH | Nov 18, 1997 | Substantially Equivalent | Urohealth Systems, Inc. |
| K963795 | VISION-SCIENCES MODEL B-F100 BRONCHOSCOPE WITH MODEL BS-F21 DISPOSABLE ENDOSHEATH | Dec 23, 1996 | Substantially Equivalent | Vision-Sciences, Inc. |
| K963252 | TBAN | Sep 20, 1996 | Substantially Equivalent | Boston Scientific Corp |
| K963033 | BF 240/P240/IT240 BRONCHOVIDEOSCOPE & ACCESSORIES | Sep 09, 1996 | Substantially Equivalent | Olympus America, Inc. |
| K962901 | OLYMPUS B5-2C/B7-2C BALLOON CATHETER | Aug 20, 1996 | Substantially Equivalent | Olympus America, Inc. |
| K962485 | OLYMPUS FG SERIES OF RAT TOOTH GRASPING FORCEPS (ENT) | Aug 20, 1996 | Substantially Equivalent | Olympus America, Inc. |
| K962533 | OLYPUS FG SERIES GRASPING FORCEPS | Aug 09, 1996 | Substantially Equivalent | Olympus America, Inc. |
| K962380 | OLYMPUS BF TYPE 200 VIDEO BRONCHSCOPES(BF-200/BF-P200/BF-IT200) | Aug 09, 1996 | Substantially Equivalent | Olympus America, Inc. |
| K962367 | OLYMPUS BASKET GRASPERS | Aug 05, 1996 | Substantially Equivalent | Olympus America, Inc. |
| K962378 | OLYMPUS FG-45/46-1 GRASPING FORCEPS | Aug 02, 1996 | Substantially Equivalent | Olympus America, Inc. |
| K962555 | OLYMPUS FB SERIES BIOPSY FORCEPS | Jul 30, 1996 | Substantially Equivalent | Olympus America, Inc. |
| K962736 | MILL-ROSE LARYNGOSCOPIC INJECTION NEEDLE | Jul 29, 1996 | Substantially Equivalent | Mill-Rose Laboratory |
| K961178 | KARL STORZ INTUBATION FIBERSCOPE | May 14, 1996 | Substantially Equivalent | KARL STORZ Endoscopy-America, Inc. |
| K960880 | MILL-ROSE BLIND MICROBIOLOGY BRUSH | Apr 29, 1996 | Substantially Equivalent | Mill-Rose Laboratory |
| K960791 | KARL STORZ HUZLY HIGH-FREQUENCY CUTTING LOOPS | Mar 11, 1996 | Substantially Equivalent | KARL STORZ Endoscopy-America, Inc. |
| K954797 | KARL STORZ RHINO-LARYNGO-BRONCHO FIBERSCOPE, FIBERSCOPE FOR BRONCHOSCOPY | Jan 17, 1996 | Substantially Equivalent | KARL STORZ Endoscopy-America, Inc. |
| K945268 | OPTUS BRONCHOSCOPES | Dec 21, 1995 | Substantially Equivalent | Optus, Inc. |
| K954707 | BRONCHOSCOPE | Nov 22, 1995 | Substantially Equivalent | Fujinon, Inc. |
| K954125 | SAUER ENDOSCOPE GUIDE AND INTUBATION AID | Oct 06, 1995 | Substantially Equivalent | KARL STORZ Endoscopy-America, Inc. |
| K953596 | DISTENDING DIVERTICULOSCOPE | Sep 26, 1995 | Substantially Equivalent | KARL STORZ Endoscopy-America, Inc. |
| K950925 | JEDMED LARYNGEAL SCOPE | Aug 11, 1995 | Substantially Equivalent | Jedmed Instrument Co. |
| K952081 | KARL STORZ CATHETERS, ADAPTORS, SUCTION/IRRIGATION CATHETERS, TUBING | Jul 03, 1995 | Substantially Equivalent | KARL STORZ Endoscopy-America, Inc. |
| K951826 | KARL STORZ TRACHEAL HIGH FREQUENCY RESECTOSCOPE | May 15, 1995 | Substantially Equivalent | KARL STORZ Endoscopy-America, Inc. |
| K951199 | FB-18X, FIBER BRONCHOSCOPE | Apr 10, 1995 | Substantially Equivalent | Pentax Precision Instrument Corp. |
| K950965 | KARL STORZ STENT APPLICATOR FORCEPS | Mar 31, 1995 | Substantially Equivalent | KARL STORZ Endoscopy-America, Inc. |
| K951051 | RITE-BITE BIOPSY FORCEPS | Mar 24, 1995 | Substantially Equivalent | Mill-Rose Laboratory |
| K950786 | OLYMPUS BIOPSY FORCEPS MODEL FB-44 | Mar 06, 1995 | Substantially Equivalent | Olympus America, Inc. |
| K950636 | OLYMPUS DISPOSABLE BIOPSY FORCEPS | Feb 27, 1995 | Substantially Equivalent | Olympus America, Inc. |
| K931442 | 11274 AB FLEXIBLE PEDIATRIC BRONCHOSCOPE | Jan 24, 1995 | Substantially Equivalent | KARL STORZ Endoscopy-America, Inc. |
| K944976 | BRONCHOSCOPE,NON-RIGID | Dec 21, 1994 | Substantially Equivalent | Citation Medical Corp. |
| K944649 | MILL-ROSE HARRELL BRONCHIAL BRUSH | Nov 30, 1994 | Substantially Equivalent | Mill-Rose Laboratory |
| K944650 | WANG BRONCHIAL NEEDLE BRUSH | Nov 22, 1994 | Substantially Equivalent | Mill-Rose Laboratory |
| K943700 | KARL STORZ BRONCHOSCOPE ACCESSORIES | Aug 23, 1994 | Substantially Equivalent | KARL STORZ Endoscopy-America, Inc. |
| K942388 | TAS-(VARIOUS) ULTRATHIN FLEXIBLE ENDOSCOPE | Aug 17, 1994 | Substantially Equivalent | Technology Marketing Group |
| K941264 | RICHARD ROD LENS LARYNGOSCOPE | Jul 18, 1994 | Substantially Equivalent | Smith & Nephew Richards, Inc. |
| K941161 | FLEXIBLE GRASPING FORCEPS | May 04, 1994 | Substantially Equivalent | Surgical Technologies, Inc. |
| K940521 | MILL-ROSE PROTECTED TRANSLARYNGOSCOPIC CATHETER | May 04, 1994 | Substantially Equivalent | Mill-Rose Laboratory |
| K941158 | FLEXIBLE BIOPSY CUP FORCEPS | Apr 28, 1994 | Substantially Equivalent | Surgical Technologies, Inc. |
| K934920 | VB-1830/VB-1530, VIDEO BRONCHOSCOPE | Jan 26, 1994 | Substantially Equivalent | Pentax Precision Instrument Corp. |
| K933433 | MODIFIED BRONCHOSCOPE AND ACCESSORIES | Nov 01, 1993 | Substantially Equivalent | Fujinon, Inc. |
| K931154 | EVIS 200 SYSTEM | Oct 07, 1993 | Substantially Equivalent | Olympus Corp. |
| K922204 | MILL-ROSE PULMONARY FORCEPS | Jul 13, 1993 | Substantially Equivalent | Mill-Rose Laboratory |
| K926430 | CANNULATED BIOPSY FORCEPS | Mar 26, 1993 | Substantially Equivalent | Thomasville Medical Assoc. |
| K923847 | DISPOSABLE BRONCHOSCOPE BIOPSY FORCEPS | Nov 18, 1992 | Substantially Equivalent | Wilson-Cook Medical, Inc. |
| K922937 | FLEXIBLE FIBER OPTIC ENDOSCOPE | Sep 14, 1992 | Substantially Equivalent | Optimed Technologies, Inc. |
| K921393 | IMAGICA MICRO-ENDOSCOPE | Aug 20, 1992 | Substantially Equivalent | Fiberoptic Medical Products, Inc. |
| K915816 | BITE BLOCK/MOUTHPIECE FOR ENDOSCOPY | Mar 27, 1992 | Substantially Equivalent | Gi Supply |
| K920025 | OLYMPUS DISPOSABLE SUCTION VALVE | Mar 24, 1992 | Substantially Equivalent | Olympus Corp. |
| K914181 | WANG/MILL-ROSE TRANSBRONCHIAL ASPIRATION NEEDLE | Dec 10, 1991 | Substantially Equivalent | Mill-Rose Laboratory |
| K910536 | PROTECTED BRONCHOALVEOLAR LAVAGE BALLOON CATHETER | Sep 24, 1991 | Substantially Equivalent | Mill-Rose Laboratory |
| K911922 | BRONCHOSCOPE ACCESSORY, NSN 6515-00-315-2200 | Jul 29, 1991 | Substantially Equivalent | Delta Industries, Inc. |
| K911412 | OLYMPUS DISPOSABLE BIOPSY VALVE | Jun 28, 1991 | Substantially Equivalent | Olympus Corp. |
| K910423 | BRONCHOSCOPE BF-N20 | Apr 29, 1991 | Substantially Equivalent | Olympus Corp. |
| K895948 | PORT-O-SCOPE(TM) | Mar 27, 1990 | Substantially Equivalent | North American Medical Products, Inc. |
| K896146 | BIOPSY FORCEPS, (NON-RIGID) | Mar 09, 1990 | Substantially Equivalent | Portlyn Corp. |
| K893006 | EXMOOR BITE BUFFER | Mar 05, 1990 | Substantially Equivalent | Exmoor Plastics , Ltd. |
| K895415 | BIOPSY FORCEPS | Oct 31, 1989 | Substantially Equivalent | Symbiosis Corp. |
| K892687 | CANNULATED BIOPSY FORCEPS | Jun 21, 1989 | Substantially Equivalent | Zinnanti Surgical Instruments, Inc. |
| K870063 | CO2 LASER BRONCHOSCOPE SET | Mar 09, 1987 | Substantially Equivalent | Tti Medical |
| K862835 | CO2 FIBEROPTIC DELIVERY SYSTEM/BRONCHOSCOPIC USE | Feb 05, 1987 | Substantially Equivalent | Cooper Lasersonics, Inc. |
| K854414 | DUMON/HARRELL | Mar 12, 1986 | Substantially Equivalent | Bryan Corp. |
| K854581 | MACHIDA SEMI-RIGID BRONCHOSCOPE FBS-6R-50 | Feb 28, 1986 | Substantially Equivalent | Machida America, Inc. |
| K844834 | MACHIDA FLEXIBLE NASOPHARYNGO-LARYNGOSCOPE FNS-1 | Jun 11, 1985 | Substantially Equivalent | Machida America, Inc. |
| K833483 | ENDOSCOPIC COUPLER | Feb 10, 1984 | Substantially Equivalent | Merrimack Laboratories |
| K832492 | BRONCHO FIBERSCOPE FB-19C | Sep 20, 1983 | Substantially Equivalent | Pentax Precision Instrument Corp. |
| K832449 | LARYNGOTELESCOPE CURVED MLC-1 | Sep 20, 1983 | Substantially Equivalent | Pentax Precision Instrument Corp. |
| K832010 | BRONCHO-FIBERSCOPE | Aug 01, 1983 | Substantially Equivalent | KARL STORZ Endoscopy-America, Inc. |
| K831240 | LASER BRONCHOSCOPE | Jul 26, 1983 | Substantially Equivalent | Eder Instrument Co, Inc. |
| K822844 | PENTAX BRONCHOFIBERSCOPE #FB-19E | Oct 26, 1982 | Substantially Equivalent | Pentax Precision Instrument Corp. |
| K822257 | VARIOUS TYPES OF LIGHT SOURCE HANDLES | Oct 26, 1982 | Substantially Equivalent | Kelleher Corp. |
| K822180 | RIGID FIBEROPTIC ENDOSCOPES | Aug 20, 1982 | Substantially Equivalent | Kelleher Corp. |
| K822136 | LASER BRONCHOSCOPE | Aug 16, 1982 | Substantially Equivalent | Laser Industries of Tel Aviv |
| K811218 | ACMI ASPIRATOR KIT #8808 | Jul 01, 1981 | Substantially Equivalent | American Cystocope Makers, Inc. |
| K811059 | PENTAX BRONCHOFIBERSCOPE #FB-15A | May 27, 1981 | Substantially Equivalent | Pentax Precision Instrument Corp. |
| K811181 | MODEL FBS-1, FLEXIBLE BRONCHOSCOPE | May 13, 1981 | Substantially Equivalent | American Optical Corp. |
| K792342 | PENTAX BROCHOFIBERSCOPE MODEL FB-17D, | Dec 27, 1979 | Substantially Equivalent | Pentax Precision Instrument Corp. |
| K792267 | PENTEX BRONCHOFIBERSCOPE MODEL FB-17A | Dec 19, 1979 | Substantially Equivalent | Pentax Precision Instrument Corp. |
| K770500 | 3 PORT LUER | Apr 05, 1977 | Substantially Equivalent | Unimetrics Corp. |
| K760171 | FIBERBRONCHOSCOPE (PENTAX FB-17A) | Jul 19, 1976 | Substantially Equivalent | Pilling Co. |
FEI Numbers
This FDA classification entry is associated with 163 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 163 registration numbers. Click on an entry to view related FDA registrations.