Andorate Biopsy Valve, Andorate Biopsy Irrigator
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K200481 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 Biopsy Valve and Andorate Biopsy Irrigator are endoscope channel accessories designed to facilitate biopsy procedures. These devices control fluid flow and valve operation during tissue sampling in endoscopic examinations, ensuring precise irrigation and suction within the endoscope channel for improved procedural efficiency and safety.
Supplied as single-use devices, these accessories are intended for use in gastroenterology and urology settings. They are classified as Class II medical devices under FDA regulations and comply with the Medical Device Regulation (MDR). The Andorate Biopsy Valve and Andorate Biopsy Irrigator are non-sterile and must be sterilized prior to first use, adhering to standard medical sterilization protocols. Each device is authorized under the FDA 510(k) clearance process and is listed under the product code ODC.
Frequently asked questions
Are the Andorate Biopsy Valve and Andorate Biopsy Irrigator designed for reuse, or are they intended for single-use only?
The Andorate Biopsy Valve and Andorate Biopsy Irrigator are explicitly supplied as single-use devices. While they are non-sterile and require sterilization prior to first use, this does not imply reuse—each device is intended for one-time use in a biopsy procedure before disposal. Sterilization is only necessary to prepare the non-sterile packaging for initial use.
What medical specialties are these devices primarily intended for, and how do they improve procedural efficiency?
These devices are designed for gastroenterology and urology settings, as indicated by their advisory committee classification (GU). They control fluid flow and valve operation during tissue sampling, enabling precise irrigation and suction within the endoscope channel. This precision reduces procedural complications, minimizes contamination risks, and enhances operator control, thereby improving efficiency and safety during biopsies.
How should the Andorate Biopsy Valve and Andorate Biopsy Irrigator be stored before use, given they are non-sterile?
Since the devices are non-sterile, they must be stored in their original packaging in a clean, dry environment away from direct sunlight or extreme temperatures. Prior to first use, they must undergo standard medical sterilization protocols (e.g., autoclave, ethylene oxide, or gamma irradiation) to ensure sterility before insertion into the endoscope channel. Always follow the manufacturer’s sterilization instructions to maintain device integrity.
What regulatory pathways have these devices undergone, and how does that affect their use in clinical settings?
The Andorate Biopsy Valve and Andorate Biopsy Irrigator are authorized through the FDA 510(k) clearance process and comply with the Medical Device Regulation (MDR). They are classified as Class II devices under FDA regulations, meaning they undergo rigorous premarket review to ensure safety and effectiveness. Clinicians can rely on these clearances as evidence of regulatory compliance, though local institutional policies should still dictate specific procedural protocols.
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 | K200481 | Class II | Active |
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Manufacturer
- Manufacturer
- Ga Health Company Limited
Sources (2)
- FDA 510(k) K200481 24 fields · synced Oct 6, 2026
- EUDAMED 1 fields · synced May 18, 2026