EOQ
- Product code
- EOQ
- Device name
- Bronchoscope (Flexible Or Rigid)
- Device class
- Class 2
- 21 CFR
- 21 CFR 874.4680
- Medical specialty
- Ear, Nose, Throat
- Marketing pathway
- 510(K)
- 510(k) clearances (last 3 years)
- 42
- Summaries archived here
- 37 (direct download)
- 510(k) clearances (all years, FDA)
- 241 (all years; only the last 3 years are listed here)
FDA classification 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) clearances, last 3 years (42)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K260382 | 2026-07-25 | Auris Health, Inc. | MONARCH Platform (MON-000008) | FDA |
| K254037 | 2026-07-10 | Free Flow Medical, Inc. | LungFlow Airway Catheter | |
| K253137 | 2026-06-16 | Fujifilm Corporation | FUJIFILM Endoscope Model EB-840S; FUJIFILM Endoscope… | |
| K260565 | 2026-05-14 | Elucent Medical | SmartClip Delivery Catheter (ADR-1715) | |
| K252341 | 2026-04-23 | Olympus Medical Systems Corp. | EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-Q190); … | |
| K260420 | 2026-04-08 | MacroLux Medical Technology Co., Ltd. | LoopView® Single-Use Digital Flexible Bronchoscope (… | |
| K250863 | 2025-12-12 | Fujifilm Corporation | FUJIFILM Ultrasonic Endoscope EB-710US | |
| K251731 | 2025-12-05 | Karl Storz SE & CO. KG | KARL STORZ Flexible Intubation Video Endoscope Ste… | |
| K251894 | 2025-09-23 | Himaging Technology (Shanghai) Co., Lt… | Himaging Bronchscope System | |
| K252045 | 2025-09-23 | Intuitive Surgical, Inc. | Ion Endoluminal System (IF1000) | |
| K252528 | 2025-09-05 | Intuitive Surgical, Inc. | Ion Endoluminal System (IF1000) | |
| K251752 | 2025-08-27 | Shanghai AnQing Medical Instrument Co.… | Flexible Bronchoscope (BS27U-12EU, BS27U-12US, BS38U… | |
| K251823 | 2025-08-11 | Zhejiang UE Medical Corp. | UE BRONCHO Single-Use Bronchoscopes (EBS-380C); UE B… | |
| K250232 | 2025-07-25 | Hunan Vathin Medical Instrument Co., L… | Vathin® Video Bronchoscope System | |
| K250862 | 2025-06-23 | Olympus Medical Systems Corp. | EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-XP190);… | |
| K244017 | 2025-06-13 | Fujifilm Corporation | FUJIFILM Endoscope Model EB-710P; FUJIFILM Processor… | |
| K250118 | 2025-06-04 | Olympus Medical Systems Corporation | Disposable Balloon Catheter B5-2C | |
| K250957 | 2025-05-30 | Olympus Medical Systems Corporation | Disposable Biopsy Forceps (FB-211D); Disposable Biop… | |
| K243497 | 2025-05-29 | Shanghai AnQing Medical Instrument Co.… | Portable Video Processor (EA101), Flexible Bronchosc… | FDA |
| K242793 | 2025-05-28 | Shenzhen Insighters Medical Technology… | Insighters Single-use Bronchoscope/Insight Bimodel-… | |
| K243541 | 2025-04-30 | Contra Healthcare Solutions, LLC | LumiRex Bronchoscope | |
| K250210 | 2025-03-19 | Scivita Medical Technology Co., Ltd. | Broncho Videoscope System (Single-use Broncho Video… | |
| K242010 | 2025-03-14 | Shenzhen Sanping Image Technology Co.,… | Bronchoscope System, The Single-use Bronchoscope (Si… | |
| K242324 | 2025-02-06 | Novatech SA | DUTAU-NOVATECH® | |
| K243219 | 2025-01-23 | Auris Health, Inc. | MONARCH Platform (MON-000008) | |
| K242416 | 2025-01-16 | Hunan Vathin Medical Instrument Co., L… | Single-use Flexible Bronchoscope: BC-E1C10, BC-E1C11… | FDA |
| K241612 | 2024-10-29 | Hunan Vathin Medical Instrument Co., L… | Video Bronchoscope System; Single-use Flexible Bronc… | |
| K240289 | 2024-10-23 | Scivita Medical Technology Co., Ltd. | Full HD Endoscopic Image Processor (HDVS-S200A, HDVS… | |
| K242070 | 2024-09-24 | Intuitive Surgical, Inc. | Ion Endoluminal System (IF 1000) | |
| K232601 | 2024-05-31 | Broncus Medical, Inc. | BroncTru Transbronchial Access Tool | |
| K234113 | 2024-05-01 | Medimaging Integrated Solution, Inc (M… | MiiS Horus Bronchoscope; MiiS Horus Endoscope Displa… | |
| K232038 | 2024-04-26 | Broncus Medical, Inc. | BioStar Single Use Transbronchial Aspiration Needle | FDA |
| K233779 | 2024-04-05 | MacroLux Medical Technology Co., Ltd. | LoopView® Single-Use Digital Flexible Bronchoscope (… | FDA |
| K240135 | 2024-04-03 | Intuitive Surgical, Inc. | Ion Endoluminal System (Ion Fully Articulating Cat… | |
| K231107 | 2024-02-15 | Hunan Endoso Life Technology Co., Ltd. | Bronchoscope System | |
| K240075 | 2024-02-07 | FUJIFILM Healthcare Americas Corporati… | FUJIFILM Endoscope Model EB-710XT | |
| K232860 | 2024-01-18 | Pentax of America, Inc. | PENTAX Medical Video Processor EPK-i8020c, PENTAX Me… | |
| K231970 | 2024-01-12 | Pentax of America, Inc. | PENTAX Medical Single Use Video Bronchoscope EB11-S0… | |
| K233671 | 2024-01-04 | Ambu A/S | Ambu® aScope 5 Broncho 4.2/2.2; Ambu® aScope 5 Bro… | |
| K232984 | 2023-12-18 | Intuitive Surgical, Inc. | Ion Endoluminal System (IF1000) | |
| K231521 | 2023-11-14 | Scivita Medical Technology Co., Ltd. | Broncho Videoscope System | |
| K232582 | 2023-09-20 | Ambu A/S | Ambu® aScope 5 Broncho 4.2/2.2 Sampler Set |
Official FDA classification page: EOQ
Classification and pathway per current FDA publications. Data from openFDA (CC0).