EOQ

Bronchoscope (Flexible Or Rigid)

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).

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (42)

Last three years. Most recent: 2026-07-25.

NumberDecision dateApplicantDevice nameSummary
K2603822026-07-25Auris Health, Inc.MONARCH™ Platform (MON-000008)FDA
K2540372026-07-10Free Flow Medical, Inc.LungFlow Airway CatheterPDF
K2531372026-06-16Fujifilm CorporationFUJIFILM Endoscope Model EB-840S; FUJIFILM Endoscope…PDF
K2605652026-05-14Elucent MedicalSmartClip Delivery Catheter (ADR-1715)PDF
K2523412026-04-23Olympus Medical Systems Corp.EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-Q190); …PDF
K2604202026-04-08MacroLux Medical Technology Co., Ltd.LoopView® Single-Use Digital Flexible Bronchoscope (…PDF
K2508632025-12-12Fujifilm CorporationFUJIFILM Ultrasonic Endoscope EB-710USPDF
K2517312025-12-05Karl Storz SE & CO. KGKARL STORZ Flexible Intubation Video Endoscope – Ste…PDF
K2518942025-09-23Himaging Technology (Shanghai) Co., Lt…Himaging Bronchscope SystemPDF
K2520452025-09-23Intuitive Surgical, Inc.Ion Endoluminal System (IF1000)PDF
K2525282025-09-05Intuitive Surgical, Inc.Ion Endoluminal System (IF1000)PDF
K2517522025-08-27Shanghai AnQing Medical Instrument Co.…Flexible Bronchoscope (BS27U-12EU, BS27U-12US, BS38U…PDF
K2518232025-08-11Zhejiang UE Medical Corp.UE BRONCHO Single-Use Bronchoscopes (EBS-380C); UE B…PDF
K2502322025-07-25Hunan Vathin Medical Instrument Co., L…Vathin® Video Bronchoscope SystemPDF
K2508622025-06-23Olympus Medical Systems Corp.EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-XP190);…PDF
K2440172025-06-13Fujifilm CorporationFUJIFILM Endoscope Model EB-710P; FUJIFILM Processor…PDF
K2501182025-06-04Olympus Medical Systems CorporationDisposable Balloon Catheter B5-2CPDF
K2509572025-05-30Olympus Medical Systems CorporationDisposable Biopsy Forceps (FB-211D); Disposable Biop…PDF
K2434972025-05-29Shanghai AnQing Medical Instrument Co.…Portable Video Processor (EA101), Flexible Bronchosc…FDA
K2427932025-05-28Shenzhen Insighters Medical Technology…Insighters™ Single-use Bronchoscope/Insight Bimodel-…PDF
K2435412025-04-30Contra Healthcare Solutions, LLCLumiRex BronchoscopePDF
K2502102025-03-19Scivita Medical Technology Co., Ltd.Broncho Videoscope System (Single-use Broncho Video…PDF
K2420102025-03-14Shenzhen Sanping Image Technology Co.,…Bronchoscope System, The Single-use Bronchoscope (Si…PDF
K2423242025-02-06Novatech SADUTAU-NOVATECH®PDF
K2432192025-01-23Auris Health, Inc.MONARCH™ Platform (MON-000008)PDF
K2424162025-01-16Hunan Vathin Medical Instrument Co., L…Single-use Flexible Bronchoscope: BC-E1C10, BC-E1C11…FDA
K2416122024-10-29Hunan Vathin Medical Instrument Co., L…Video Bronchoscope System; Single-use Flexible Bronc…PDF
K2402892024-10-23Scivita Medical Technology Co., Ltd.Full HD Endoscopic Image Processor (HDVS-S200A, HDVS…PDF
K2420702024-09-24Intuitive Surgical, Inc.Ion Endoluminal System (IF 1000)PDF
K2326012024-05-31Broncus Medical, Inc.BroncTru™ Transbronchial Access ToolPDF
K2341132024-05-01Medimaging Integrated Solution, Inc (M…MiiS Horus Bronchoscope; MiiS Horus Endoscope Displa…PDF
K2320382024-04-26Broncus Medical, Inc.BioStar Single Use Transbronchial Aspiration NeedleFDA
K2337792024-04-05MacroLux Medical Technology Co., Ltd.LoopView® Single-Use Digital Flexible Bronchoscope (…FDA
K2401352024-04-03Intuitive Surgical, Inc.Ion™ Endoluminal System (Ion™ Fully Articulating Cat…PDF
K2311072024-02-15Hunan Endoso Life Technology Co., Ltd.Bronchoscope SystemPDF
K2400752024-02-07FUJIFILM Healthcare Americas Corporati…FUJIFILM Endoscope Model EB-710XTPDF
K2328602024-01-18Pentax of America, Inc.PENTAX Medical Video Processor EPK-i8020c, PENTAX Me…PDF
K2319702024-01-12Pentax of America, Inc.PENTAX Medical Single Use Video Bronchoscope EB11-S0…PDF
K2336712024-01-04Ambu A/SAmbu® aScope™ 5 Broncho 4.2/2.2; Ambu® aScope™ 5 Bro…PDF
K2329842023-12-18Intuitive Surgical, Inc.Ion Endoluminal System (IF1000)PDF
K2315212023-11-14Scivita Medical Technology Co., Ltd.Broncho Videoscope SystemPDF
K2325822023-09-20Ambu A/SAmbu® aScope™ 5 Broncho 4.2/2.2 Sampler SetPDF

37 summaries are archived here for direct download.

Official FDA classification page: EOQ
Classification and pathway per current FDA publications. Data from openFDA (CC0).