AquaPulse Auxiliary Water Connector
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K200479 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 AquaPulse Auxiliary Water Connector is an endoscopic irrigation/suction system accessory designed to provide auxiliary water supply for endoscopic procedures. It connects to irrigation systems to facilitate fluid delivery during gastrointestinal or urological endoscopy, ensuring proper irrigation and suction functionality.
This connector is supplied as a reusable medical device, intended for use in clinical settings such as endoscopy suites. It is classified as a Class II device under FDA regulations (876.1500) and has received FDA 510(k) clearance and MDR authorization. The device is not specified as MRI-safe or single-use, and no sterility requirements are noted in the provided data.
Frequently asked questions
What is the primary purpose of the AquaPulse Auxiliary Water Connector in endoscopic procedures?
The AquaPulse Auxiliary Water Connector is designed to provide an auxiliary water supply for endoscopic irrigation/suction systems. It connects to irrigation systems to ensure proper fluid delivery during gastrointestinal or urological endoscopy, helping maintain optimal irrigation and suction functionality during procedures.
Is the AquaPulse Auxiliary Water Connector intended for single-use or reusable applications?
The AquaPulse Auxiliary Water Connector is explicitly described as a reusable medical device. It is intended for use in clinical settings like endoscopy suites, where it can be cleaned and reused across multiple procedures.
What regulatory pathways has the AquaPulse Auxiliary Water Connector undergone, and what does that mean for its use?
The device has received FDA 510(k) clearance and MDR authorization, confirming it meets regulatory standards for safety and performance. The FDA classification under 876.1500 (Endoscopic Irrigation/Suction System) and the Gastroenterology/Urology advisory committee involvement indicate it is intended for use in those specialized fields. This means it has undergone evaluation to ensure compliance with applicable regulations before market authorization.
Are there any specific storage or handling instructions mentioned for the AquaPulse Auxiliary Water Connector?
The provided data does not specify explicit storage or handling instructions for the AquaPulse Auxiliary Water Connector. However, as a reusable device, it should be cleaned, disinfected, and stored according to standard medical device reprocessing protocols to maintain sterility and functionality between uses.
Does the AquaPulse Auxiliary Water Connector come in multiple sizes or models, or is it a single standardized unit?
The provided data does not detail specific sizes or models of the AquaPulse Auxiliary Water Connector. It is described as a single device type intended for auxiliary water supply in endoscopic procedures, without mention of variations in sizing or configuration.
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 | K200479 | Class II | Active |
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Manufacturer
- Manufacturer
- Ga Health Company Limited
Sources (2)
- FDA 510(k) K200479 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 18, 2026