Broncho Videoscope System (Single-use Broncho Videoscope (SBV-1A-B, SBV-1A-P, S…
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K250210 FDA 510(k)
- FDA Product Code
- EOQ FDA 510(k)
- Models / Variants
- 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) FDA 510(k)EUDAMED
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 874.4680 FDA 510(k)
- Regulation Number
- 874.4680 FDA 510(k)
- Advisory Committee
- Ear, Nose, Throat FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Broncho Videoscope System is a flexible bronchoscopy device designed for visualizing the airway passages. It combines single-use bronchoscope probes with high-definition endoscopic image processors to provide real-time, high-resolution imaging of the tracheobronchial tree, facilitating diagnostic and therapeutic interventions in respiratory medicine.
The system comprises single-use bronchoscope models (SBV-1A, SBV-1B, SBV-1C) paired with either Full HD or standard endoscopic image processors (HDVS-S300 or HDVS-S100 series). Supplied as a sterile, single-use assembly, the device is intended for use in clinical settings requiring MRI-safe imaging equipment. Authorized under FDA 510(k) and MDR, it adheres to regulatory standards for endoscopic visualization systems.
Frequently asked questions
What are the key differences between the Full HD and standard endoscopic image processors in the Broncho Videoscope System?
The Full HD processors (HDVS-S300 series) provide higher-resolution imaging compared to the standard processors (HDVS-S100 series). This means the Full HD models deliver clearer, more detailed real-time visualization of the tracheobronchial tree, which can enhance diagnostic precision and procedural guidance during bronchoscopy.
Are the bronchoscope probes in this system reusable or single-use, and how does this affect their sterility?
The bronchoscope probes (SBV-1A, SBV-1B, SBV-1C models) are explicitly designed as single-use devices. This ensures each probe is sterile upon opening, eliminating the need for reprocessing and reducing the risk of cross-contamination between patients.
What types of bronchoscopy procedures is this system compatible with, and why is MRI safety important?
The system is designed for diagnostic and therapeutic interventions in respiratory medicine, such as visualizing airway passages for biopsies, foreign body removal, or airway clearance. MRI safety is emphasized because the bronchoscope probes are compatible with MRI environments, allowing for combined imaging or procedures where MRI guidance may be beneficial.
How do I determine which bronchoscope model (e.g., SBV-1A-B vs. SBV-1C-P) is best suited for my clinical needs?
The model selection depends on the specific clinical application and patient requirements. The suffixes indicate variations in design or features (e.g., ‘B’ or ‘P’ may denote differences like bendability or port configuration), but the manufacturer’s documentation should be consulted for precise details. For example, the SBV-1C series may offer enhanced flexibility or additional ports compared to the SBV-1A series, which could be critical for complex procedures.
What storage or handling instructions should I follow for the Broncho Videoscope System to maintain its performance?
Since the bronchoscope probes are single-use and sterile, they should be stored in their original packaging in a clean, dry environment away from direct sunlight or extreme temperatures. The image processors (HDVS-S series) should be stored according to the manufacturer’s guidelines, typically in a controlled environment to prevent dust or moisture damage, ensuring optimal functionality for high-definition imaging.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K250210 | Class II | Active |
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Manufacturer
- Manufacturer
- Scivita Medical Technology Co., Ltd.
Sources (2)
- FDA 510(k) K250210 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 18, 2026