Evis Exera III Bronchovideoscope
BF-H190 Eeiii High DEF Diagnos IC Bronch
21manufacturers in China registered for this device type
10catalogue numbers in this listing
19510(k) clearances naming this product code
Who Else Makes It
Concentrated in Guangdong (7), Zhejiang (5), Jiangsu (4). 5 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Flexicare Medical (Dongguan) Ltd. | Dongguan | Guangdong | Contract manufacturer | 48 |
| Guangdong MacroLux Medical Technology Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 9 |
| Ningbo Wise Optomech Technology Corporation | Ningbo | Zhejiang | Contract manufacturer | 4 |
| Hangzhou Broncus Medical Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 1 |
| Tianjin Puli Ark Medical Technology Co., Ltd. | Dongli District | Tianjin | Contract manufacturer | 1 |
| Micro-Tech (Nanjing) Co., Ltd. | Nan Jing | Jiangsu | Contract manufacturer | 49 |
| Zhejiang Huanyi Sterilization Technology Co., Ltd. | Huzhou | Zhejiang | Contract manufacturer | 25 |
| Shenzhen Hugemed Medical Technical Development Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 22 |
| Suzhou Prosteri Medical Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 20 |
| Suzhou Virgil Medical Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 20 |
| Scivita Medical Technology Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 19 |
| Anrei Medical (Hangzhou) Co., Ltd. | Hangzhou | Zhejiang | Manufacturer | 12 |
Showing 12 of 21. All 21 manufacturers in China registered for Bronchoscope (Flexible Or Rigid)
Record
| Listed by | Olympus Medical Systems Corp., Japan |
|---|---|
| FDA product code | EOQ |
| Device type | Bronchoscope (Flexible Or Rigid) |
| Device class | Class 2 |
| Regulation | 21 CFR 874.4680 |
| Establishment | Specification developer, Manufacturer, Exporter |
| 510(k) | K250862 |
| Record published | 2019-10-22 |
| Record revised | 2026-02-17 (version 10) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | High-level Disinfectant, Ethylene Oxide, Hydrogen Peroxide |
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| OLYMPUS BF-XT190 | In distribution | |
| OLYMPUS BF-1TH190 | In distribution | |
| OLYMPUS BF-XP190 | In distribution | |
| OLYMPUS BF-1TH190 | In distribution | |
| OLYMPUS BF-XP190 | In distribution | |
| OLYMPUS BF-H190 | In distribution | |
| OLYMPUS BF-P190 | In distribution | |
| OLYMPUS BF-Q190 | In distribution | |
| OLYMPUS BF-P190 | In distribution | |
| OLYMPUS BF-H190 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Bronchoscope (Flexible Or Rigid) | Karl Storz GmbH & Co. KG | 248 |
| Pentax | Hoya Corporation | 39 |
| Biopsy Forceps | Olympus Medical Systems Corp. | 31 |
| Single-Use flexible Video Bronchoscope | Hunan Vathin Medical Instrument Co., Ltd. | 27 |
| Pilling | Teleflex Medical LLC | 24 |
| Silicone cap | Efer Endoscopy | 22 |
| Bronchoscope (Flexible Or Rigid) | Intuitive Surgical, Inc. | 20 |
| Endoso | Hunan Endoso Life Technology Co., Ltd. | 20 |
| Exalt ™ | Boston Scientific Corporation | 17 |
| Grasping Forceps | Olympus Medical Systems Corp. | 16 |
| LungVision Tool | Body Vision Medical Ltd | 16 |
| Fujifilm | Fujifilm Corporation | 15 |
Showing 12 of 255. All products under Bronchoscope (Flexible Or Rigid)
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K252341 | 2026-04-23 |
| K250862 | 2025-06-23 |
| K250118 | 2025-06-04 |
| K250957 | 2025-05-30 |
| K222861 | 2023-06-15 |
| K221631 | 2022-09-26 |
| K212667 | 2021-09-22 |
| K201300 | 2021-01-26 |
| K201758 | 2021-01-21 |
| K200342 | 2020-12-17 |
| K200397 | 2020-04-24 |
| K192164 | 2020-03-06 |
| K183419 | 2019-09-05 |
| K172726 | 2018-04-30 |
| K121959 | 2013-01-10 |
| K082720 | 2008-11-05 |
| K061313 | 2006-08-31 |
| K060243 | 2006-06-23 |
| K050220 | 2005-02-10 |
Recalls Naming This Product
19 recalls name this product by its own identifiers, the UDI on its label or the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Olympus Corporation of the Americas | 510(k) number | 2025-09-11 | Class I | Device Design | Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment. | 0 units US; 1,913 units OUS | |
| Olympus Corporation of the Americas | 510(k) number | 2025-09-11 | Class I | Device Design | Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment. | 4,297 units US; 4,290 units OUS | |
| Olympus Corporation of the Americas | 510(k) number | 2025-09-11 | Class I | Device Design | Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment. | 0 units US; 2,092 units OUS | |
| Olympus Corporation of the Americas | 510(k) number | 2025-09-11 | Class I | Device Design | Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment. | 0 units US; 1,867 units OUS | |
| Olympus Corporation of the Americas | 510(k) number | 2025-09-11 | Class I | Device Design | Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment. | 5,221 units US; 4,321 units OUS | |
| Olympus Corporation of the Americas | 510(k) number | 2025-09-11 | Class I | Device Design | Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment. | 3,046 units US; 2,414 units OUS | |
| Olympus Corporation of the Americas | 510(k) number | 2025-09-11 | Class I | Device Design | Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment. | 1 unit US; 2,306 units OUS | |
| Olympus Corporation of the Americas | 510(k) number | 2025-09-11 | Class I | Device Design | Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment. | 916 units US; 1,402 units OUS | |
| Olympus Corporation of the Americas | 510(k) number | 2025-09-11 | Class I | Device Design | Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment. | 361 units US; 258 units OUS | |
| Shirakawa Olympus Co., Ltd. | UDI-DI | 2023-12-04 | Class II | Under Investigation by firm | Olympus has updated the instructions for use: Reusable cleaning brushes have been removed from the manual cleaning. Single use brushes remain compatible. | 2600 US; 3214 OUS | |
| Shirakawa Olympus Co., Ltd. | UDI-DI | 2023-12-04 | Class II | Under Investigation by firm | Olympus has updated the instructions for use: Reusable cleaning brushes have been removed from the manual cleaning. Single use brushes remain compatible. | 1187 US; 1652 OUS | |
| Olympus Corporation of the Americas | 510(k) number | 2023-10-12 | Class I | Under Investigation by firm | There is a risk of endobronchial combustion if high-frequency cauterization is performed while supplying oxygen [and/or] the electrode section of the electrosurgical accessory is too close to the distal end of the endoscope. | 32211 devices | |
| Aizu Olympus Co., Ltd. | 510(k) number | 2023-09-25 | Class II | Under Investigation by firm | Channel air drying process was not validated, and that a small percentage of scopes returned to customers after repair had a wet channel. Water remaining in the channel of the endoscopes has the potential for contamination that could lead t | 1123 units | |
| Olympus Corporation of the Americas | 510(k) number | 2023-07-27 | Class II | Labeling Change Control | Complaint of endoscope model becoming lodged in the endotracheal tube connector due to diameter being too large. | 9449 units | |
| Olympus Corporation of the Americas | UDI-DI | 2023-07-27 | Class II | Labeling Change Control | Complaint of endoscope model becoming lodged in the endotracheal tube connector due to diameter being too large. | 235 units | |
| Olympus Corporation of the Americas | UDI-DI | 2023-07-27 | Class II | Labeling Change Control | Complaint of endoscope model becoming lodged in the endotracheal tube connector due to diameter being too large. | 3949 units | |
| Olympus Corporation of the Americas | 510(k) number | 2023-06-08 | Class I | Under Investigation by firm | There have been complaints of endobronchial combustion during therapeutic laser procedures with the bronchoscope. | 1 units | |
| Olympus Corporation of the Americas | 510(k) number | 2023-06-08 | Class I | Under Investigation by firm | There have been complaints of endobronchial combustion during therapeutic laser procedures with the bronchoscope. | 9,684 units | |
| Aizu Olympus Co., Ltd. | UDI-DI | 2022-07-20 | Class II | Under Investigation by firm | The recalled unit was utilized in a veterinary endoscopy procedure in advance of being assigned to healthcare facilities as a loaner. | 2025-01-22 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.