Bronchoscope System EOQ
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K222910 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)
The Bronchoscope System EOQ is a flexible endoscope designed for visual examination of the airways, including the trachea and bronchi. It enables diagnostic and therapeutic procedures in ear, nose, and throat (ENT) applications, providing real-time imaging for clinicians to assess respiratory tract conditions.
This system is supplied as a reusable medical device, intended for use in clinical settings such as hospitals and outpatient clinics. It adheres to FDA 510K clearance under the Ear, Nose, Throat advisory committee and EU MDR compliance, with no third-party involvement in its regulatory submission. Proper sterilization and maintenance protocols must be followed as per manufacturer guidelines to ensure safe, repeated use.
Frequently asked questions
Is this bronchoscope system designed for single-use or repeated use in clinical settings? Why does that matter?
This bronchoscope system is reusable, intended for repeated use in hospitals and outpatient clinics. Reusability matters because it requires strict adherence to manufacturer-provided sterilization and maintenance protocols to ensure safety and functionality across multiple procedures. Proper cleaning and sterilization are critical to prevent cross-contamination and maintain device integrity over time.
What types of procedures can this bronchoscope system be used for, and why is real-time imaging important?
The Bronchoscope System EOQ is designed for diagnostic and therapeutic procedures in the ear, nose, and throat (ENT) domain, specifically for visual examination of the airways—including the trachea and bronchi. Real-time imaging is important because it allows clinicians to directly assess respiratory tract conditions during the procedure, enabling immediate decision-making for biopsies, foreign body removal, or other interventions without delays.
How is the regulatory approval process for this device structured, and what does ‘substantially equivalent’ mean in this context?
This device received FDA 510(k) clearance under the Ear, Nose, and Throat (ENT) advisory committee, with a decision labeled as ‘Substantially Equivalent’ (SESE). This means the FDA determined that the Bronchoscope System EOQ has the same intended use, technological characteristics, and safety as a legally marketed predicate device already on the market. It does not imply new breakthrough technology but confirms compliance with existing safety standards for reusable bronchoscopes.
What are the key considerations for storage and handling of this reusable bronchoscope system?
Since this is a reusable device, storage and handling must follow manufacturer guidelines to preserve sterility and functionality. After use, it should be cleaned, disinfected, and sterilized before storage in a dedicated, clean environment. Proper maintenance—including inspection for damage and calibration—is essential to ensure the device remains safe and effective for repeated clinical procedures. The manufacturer’s instructions should be strictly followed to avoid contamination or mechanical failure.
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 | K222910 | Class II | Active |
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Manufacturer
Sources (2)
- FDA 510(k) K222910 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 26, 2026