Andorate Disposable Air/Water Valve, Andorate Disposable Suction Valve
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K200495 FDA 510(k)
- FDA Product Code
- ODC FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 876.1500 FDA 510(k)
- Regulation Number
- 876.1500 FDA 510(k)
- Advisory Committee
- Gastroenterology, Urology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Andorate Disposable Air/Water Valve and Andorate Disposable Suction Valve are endoscope channel accessories designed for use with gastrointestinal and urological endoscopes. These single-use devices regulate airflow, water flow, and suction within the endoscope channel, ensuring precise control during diagnostic and therapeutic procedures.
Supplied as sterile, disposable components, these valves are intended for use in clinical settings such as gastroenterology and urology. They are classified as Class II devices under FDA regulations and comply with the Medical Device Regulation (MDR). Each valve is compatible with multiple endoscope models, as indicated by the listed registration numbers, and must be discarded after a single use to maintain sterility and prevent cross-contamination.
Frequently asked questions
Are the Andorate Disposable Air/Water Valve and Suction Valve compatible with all endoscope models, or are there specific brands or types they work with?
The Andorate Disposable Air/Water Valve and Suction Valve are designed for use with gastrointestinal and urological endoscopes but are not universal across all brands. They are explicitly listed as compatible with multiple endoscope models via the provided registration numbers (e.g., 3011193403, 1825146, etc.). These numbers correspond to specific endoscope types, so compatibility should be verified against the device’s listed registration numbers before use.
How are the Andorate Disposable Air/Water Valve and Suction Valve supplied, and what should I know about their sterility?
The Andorate Disposable Air/Water Valve and Suction Valve are supplied as sterile, single-use components. They are packaged to maintain sterility until first use, ensuring no risk of cross-contamination. Since they are designed for one-time use, they must be discarded immediately after use to uphold sterility standards.
What is the regulatory pathway for these devices, and how does it impact their use in clinical settings?
The Andorate Disposable Air/Water Valve and Suction Valve are classified as Class II devices under FDA regulations and have received FDA 510(k) clearance, indicating they are deemed substantially equivalent to a legally marketed predicate device. They also comply with the Medical Device Regulation (MDR) in the EU. This regulatory clearance ensures they meet safety and performance standards for use in clinical settings like gastroenterology and urology.
Can these valves be reused, or are they strictly for single-use only?
These valves are explicitly designed for single-use only. The manufacturer emphasizes that they must be discarded after one use to prevent cross-contamination and maintain sterility. Reuse is not recommended or supported by the manufacturer’s design or regulatory compliance.
What special handling or storage instructions should be followed for the Andorate Disposable Air/Water Valve and Suction Valve?
While specific storage instructions are not detailed in the provided data, the valves are supplied sterile and as single-use items. They should be stored in their original, sealed packaging until use to preserve sterility. After opening, they must be used immediately and discarded afterward. Ensure the storage environment is clean, dry, and protected from contamination.
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 | K200495 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Ga Health Company Limited
Sources (2)
- FDA 510(k) K200495 24 fields · synced Oct 6, 2026
- EUDAMED 1 fields · synced May 18, 2026