Single-Use Broncho Videoscope
The single-use Broncho Videoscope provides endoscopic access and images for observation, diagnosis, photography, and treatment in the trachea, bronchi, and lungs. It must be connected to a…
The single-use Broncho Videoscope provides endoscopic access and images for observation, diagnosis, photography, and treatment in the trachea, bronchi, and lungs. It must be connected to a compatible HDVS-S100A or HDVS-S100D endoscopic image processor and monitor.
The flexible scope has a bending section, insertion shaft, operating section, and connector. Its single distal working channel branches proximally toward irrigation and suction connections. The SBV-1A, 1B, and 1C range shares a 600 mm working length.
Listed Item
The product is composed of a distal end, a bending section, an insertion section, an operation section, and a plug section. This Single-use Broncho Videoscope is intended to use in conjunction with Endoscopic Image Processor to provide images through the video monitor for observation, diagnosis, photography and treatment of respiratory system such as trachea, bronchi, and lungs.
Supply and Configuration
The scope is supplied sterile after ethylene oxide sterilization and is intended for one use. The range has different insertion diameters and shaft materials; the reusable image processor is a separate component. Packaged shelf life is three years.
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 | Scivita Medical Technology Co., Ltd., China |
|---|---|
| FDA product code | EOQ |
| Device type | Bronchoscope (Flexible Or Rigid) |
| Device class | Class 2 |
| Regulation | 21 CFR 874.4680 |
| Establishment | Manufacturer |
| 510(k) | K210379 |
| Record published | 2023-05-17 |
| Record revised | 2025-06-26 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Storage environment humidity 20 to 90 % RH; Storage environment temperature -40 to 55 °C; Handling environment atmospheric pressure 70 to 106 KiloPascal; Storage environment atmospheric pressure 70 to 106 KiloPascal; Handling environment humidity 20 to 80 % RH; Handling environment temperature 5 to 40 °C |
| Packaging | Pack of 22, pack of 2 |
| Distribution end date | 2024-12-31 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SBV-1B-P | In distribution | |
| SBV-1C-P | In distribution | |
| SBV-1A-B | In distribution | |
| SBV-1A-P | In distribution | |
| SBV-1B-B | In distribution | |
| SBV-1C-B | In distribution | |
| SBV-1A-B | In distribution | |
| SBV-1A-P | Withdrawn | |
| SBV-1B-P | Withdrawn | |
| SBV-1B-B | Withdrawn | |
| SBV-1C-P | Withdrawn | |
| SBV-1C-B | Withdrawn |
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 |
|---|---|
| K250210 | 2025-03-19 |
| K240289 | 2024-10-23 |
| K231521 | 2023-11-14 |
| K210379 | 2021-07-28 |
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.