Portable Video Processor (EA101), Flexible Bronchoscope BS41H-12EU, BS41H-12US,…
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K243497 FDA 510(k)
- FDA Product Code
- EOQ FDA 510(k)
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)
This device comprises a portable video processor (EA101) paired with a range of flexible bronchoscopes, including models BS41H-12EU, BS41H-12US, BS46H-17EU, BS46H-17US, BS50H-20EU, BS50H-20US, BS53H-22EU, BS53H-22US, BS55H-24EU, BS55H-24US, BS59H-28EU, and BS59H-28US. The bronchoscopes are designed for visual inspection of the airway passages, enabling diagnostic and therapeutic procedures in the ear, nose, and throat. The video processor enhances image clarity and transmission for real-time monitoring during procedures.
The system is intended for use in clinical settings by trained medical professionals. Supplied as a reusable device, it requires proper cleaning, disinfection, and maintenance as per manufacturer guidelines. The bronchoscopes are compatible with MRI environments and are classified under product code EOQ. Authorised for use under FDA 510(k) clearance (K243497) and MDR compliance, the device adheres to regulatory standards for medical imaging and endoscopic tools.
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. Sources consulted: Portable Video Processor (EA101), Flexible Bronchoscope BS41H-12EU ..., Portable Video Processor (EA101), Flexible Bronchoscope BS41H-12EU ..., Portable Video Processor (EA101), Flexible Bronchoscope BS41H-12EU ...
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 | K243497 | Class II | Active |
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Manufacturer
- Manufacturer
- Shanghai Anqing Medical Instrument Co., Ltd
- FDA Applicant
- Shanghai AnQing Medical Instrument Co., Ltd.
Sources (2)
- FDA 510(k) K243497 24 fields · synced Sep 20, 2026
- EUDAMED 1 fields · synced May 19, 2026