Vacutore Air/Water Bottle Tubing, Vacutore CO2 Tubing with Luer Connector
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K200388 FDA 510(k)
- FDA Product Code
- OCX 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 Vacutore Air/Water Bottle Tubing and Vacutore CO2 Tubing with Luer Connector are components of an Endoscopic Irrigation/Suction System, designed to facilitate air insufflation, CO₂ insufflation, and water irrigation during gastrointestinal endoscopic procedures. These tubings connect an air/CO₂ source, a sterile water bottle, and an endoscope to deliver pressurized air, CO₂, or water as required during the procedure.
The device is intended for use in clinical settings such as gastroenterology and urology, with a 24-hour multi-patient use designation. Supplied as a reusable or disposable accessory (as indicated by the product codes), it is compatible with various endoscope models, including those from Pentax and Olympus. The tubing is classified as Class II under FDA regulations and has received FDA 510(k) clearance and MDR authorization, ensuring compliance with regulatory standards for endoscopic accessories.
Frequently asked questions
What clinical specialties is this tubing designed for, and how does it integrate with procedures in those fields?
The Vacutore Air/Water Bottle Tubing and Vacutore CO₂ Tubing with Luer Connector are specifically designed for use in gastroenterology and urology procedures. They connect to an endoscope to deliver pressurized air, CO₂, or water during gastrointestinal or urological endoscopic examinations, ensuring proper insufflation, irrigation, and suction as needed. The tubing is compatible with multiple endoscope models, including those from Pentax and Olympus, making it versatile for routine and specialized diagnostic or therapeutic procedures in these specialties.
Is this tubing reusable or disposable, and what does the 24-hour multi-patient use designation mean?
The Vacutore tubing is available in both reusable and disposable versions, as indicated by the product codes. The 24-hour multi-patient use designation means it can be used across multiple patients within a single 24-hour period, provided proper cleaning, disinfection, or sterilization (for reusable versions) is performed between uses. This designation is critical for infection control in clinical settings where multiple procedures occur sequentially.
How do I determine if the tubing I need is compatible with my endoscope, and what sizes or models are available?
The tubing is compatible with a wide range of endoscope models, including those from Pentax and Olympus, as explicitly stated in the device description. While specific sizes or models aren’t detailed in the provided data, the product codes (e.g., OCX) and registration numbers reference multiple variations, suggesting compatibility with standard endoscopic irrigation/suction systems. For exact sizing or model-specific fit, consult the manufacturer’s documentation or contact GA Health Company Limited for guidance on selecting the correct tubing for your endoscope.
What regulatory pathways does this device follow, and how does that affect its use in clinical settings?
The Vacutore tubing has received FDA 510(k) clearance and MDR authorization, confirming compliance with regulatory standards for endoscopic accessories. The FDA classification as Class II and the substantially equivalent (SE) determination indicate it meets performance criteria for its intended use in air insufflation, CO₂ insufflation, and water irrigation during endoscopic procedures. Clinicians can rely on these approvals to ensure the device adheres to safety and effectiveness standards, though local regulatory requirements may still apply.
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: Vacutore Air-water Bottle Tubing with CO2 Extend, Vacutore Air-Water Bottle Tubing with CO2 Extend, Vacutore Air/Water Bottle Tubing, Vacutore CO2 Tubing with Luer ..., Vacutore Air/Water Bottle Tubing, Vacutore CO2 Tubing with Luer ...
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 | K200388 | Class II | Active |
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Manufacturer
- Manufacturer
- Ga Health Company Limited
Sources (2)
- FDA 510(k) K200388 24 fields · synced Oct 6, 2026
- EUDAMED 1 fields · synced May 18, 2026