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# Endoscopic Transhepatic Venous Needle is Class 2
- URL: https://www.fdaweb.com/endoscopic-transhepatic-venous-needle-is-class-2/
- Published: 2021-12-15T12:00:00.000Z
- Updated: 2026-09-14T17:25:57.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5150776

*Federal Register* notice: FDA is classifying the endoscopic transhepatic venous access needle into Class 2 (special controls). The action is based on a de novo classification request by Cook Ireland for its EchoTip Insight Portosystemic Pressure Gradient Measuring System. The agency has identified it as a device that is inserted through the liver into a patient’s portal/hepatic venous system under endoscopic ultrasound guidance. It is connected to a separate device intended to measure a physiological parameter. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2021-12-15/pdf/2021-27135.pdf?ref=fdaweb.com).