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.
Recent Cleared Devices (20 of 236)
Showing 20 most recent of 236 cleared devices.
| 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 |
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
