EchoTip Insight Portosystemic Pressure Gradient Measuring System
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- DEN180062 FDA 510(k)
- FDA Product Code
- QIJ FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 876.1050 FDA 510(k)
- Regulation Number
- 876.1050 FDA 510(k)
- Advisory Committee
- Gastroenterology, Urology FDA 510(k)
- FDA Decision
- DENG FDA 510(k)
The EchoTip Insight Portosystemic Pressure Gradient Measuring System is an Endoscopic Transhepatic Venous Access Needle, designed to measure portosystemic pressure gradients. This device facilitates the assessment of portal hypertension by enabling precise intravascular pressure measurements within the hepatic and portal venous systems, aiding in the evaluation of liver disease severity and treatment planning.
This system is supplied as a sterile, single-use device and is intended for use in clinical settings such as gastroenterology and urology procedures. It adheres to FDA 510(k) and MDR regulatory standards, with a classification under Device Class II (QIJ product code). Proper storage and handling are required to maintain sterility, ensuring safe and accurate pressure gradient measurements during endoscopic interventions.
Frequently asked questions
What clinical specialties primarily use the EchoTip Insight system, and why is it relevant to their procedures?
The EchoTip Insight system is primarily used in gastroenterology and urology procedures. It is designed to measure portosystemic pressure gradients, which helps assess portal hypertension—a critical factor in evaluating liver disease severity (such as cirrhosis) and guiding treatment decisions like transjugular intrahepatic portosystemic shunt (TIPS) placement. This makes it especially relevant for clinicians managing complex liver-related conditions.
Is the EchoTip Insight system reusable, or is it meant for single-use only? How does this affect its handling?
The EchoTip Insight system is sterile and intended for single-use only. This design ensures patient safety and measurement accuracy by preventing contamination between procedures. Proper storage in sealed packaging and adherence to manufacturer guidelines are essential to maintain sterility before use.
What types of pressure measurements does this device enable, and how does it differ from traditional methods?
The EchoTip Insight system enables precise intravascular pressure measurements within the hepatic and portal venous systems, specifically measuring portosystemic pressure gradients. Unlike traditional methods that rely on indirect estimates (e.g., hepatic vein pressure), this device provides direct, real-time data via an endoscopic transhepatic venous access needle, improving diagnostic accuracy for portal hypertension.
How should the EchoTip Insight system be stored to ensure it remains effective and sterile?
The system must be stored in its original, unopened packaging to preserve sterility. It should be kept in a clean, dry environment away from direct sunlight or extreme temperatures. Avoid exposing it to moisture or contamination, as this could compromise its performance and safety for single-use procedures.
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 | DEN180062 | Class II | Active |
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Manufacturer
- Manufacturer
- Cook Ireland, Ltd.
Sources (2)
- FDA 510(k) DEN180062 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 18, 2026