Andorate Suction Valve and Andorate Biopsy Valve
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K230280 FDA 510(k)
- FDA Product Code
- KTI 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 Andorate Suction Valve and Andorate Biopsy Valve are single-use, sterile accessories designed for flexible bronchoscopes. These devices regulate fluid and debris aspiration through the suction port and maintain insufflation while allowing instrument passage through the biopsy/suction channel, preventing leakage during procedures.
Supplied as sterile, single-use components, these valves are intended for use in hospital and clinic settings by physicians performing ear, nose, and throat procedures. Compatible with Olympus 160/180/190/260/290 series bronchoscopes, they adhere to FDA 510(k) and MDR regulatory standards. The valves are classified as Class II medical devices under the regulation number 874.4680.
Frequently asked questions
Are the ANDORATE® Suction Valve and ANDORATE® Biopsy Valve reusable or single-use, and why does this matter in clinical settings?
The ANDORATE® Suction Valve and ANDORATE® Biopsy Valve are sterile, single-use components. This design choice is critical in clinical settings because single-use devices reduce the risk of cross-contamination between patients, ensuring infection control and hygiene standards are maintained during procedures. Reusing medical devices can introduce pathogens, whereas single-use items eliminate this risk entirely, aligning with best practices in hospital and clinic environments.
What bronchoscopes are compatible with the ANDORATE® valves, and how do I confirm compatibility before use?
The ANDORATE® Suction Valve and ANDORATE® Biopsy Valve are designed for compatibility with Olympus 160, 180, 190, 260, and 290 series bronchoscopes. To confirm compatibility before use, verify the model number of your bronchoscope against this list. The valves are engineered to fit these specific series, ensuring proper function during aspiration, insufflation, and instrument passage without leakage. Always check the packaging or consult the manufacturer’s documentation for exact model matches.
How should the ANDORATE® valves be stored, and what precautions should be taken to maintain their sterility?
The ANDORATE® valves are sterile upon packaging and should be stored in their original, unopened packaging until use. Store them in a clean, dry environment, protected from direct sunlight, extreme temperatures, and physical damage. Avoid exposing them to moisture or contaminants, as this could compromise sterility. Once opened, the valves must be used immediately to prevent contamination. Follow the manufacturer’s storage guidelines to preserve their integrity for clinical procedures.
What regulatory pathways have the ANDORATE® valves undergone, and how does this affect their use in hospitals?
The ANDORATE® Suction Valve and ANDORATE® Biopsy Valve have undergone FDA 510(k) clearance and MDR (Medical Device Regulation) authorization, confirming they meet stringent safety and performance standards. This regulatory approval ensures the valves are classified as Class II medical devices under the EU classification 874.4680, indicating they pose moderate risk and require compliance with specific manufacturing and quality controls. Hospitals can rely on these approvals to confirm the valves are suitable for use in ear, nose, and throat procedures involving flexible bronchoscopes.
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: GAR018 Pentax Biopsy Valve | Andorate | Single-use endoscopy valves ..., ANDORATE® Suction Valve and ANDORATE® Biopsy Valve (K230280) — FDA 510 ..., ANDORATE® Valve Kit (K232118) — FDA 510 (k) | Innolitics
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 | K230280 | Class II | Active |
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Manufacturer
- Manufacturer
- Ga Health Company Limited
Sources (2)
- FDA 510(k) K230280 24 fields · synced Oct 6, 2026
- EUDAMED 1 fields · synced May 29, 2026