DEN180062 is an FDA 510(k) submission for the EchoTip Insight Portosystemic Pressure Gradient Measuring System. This device is classified as a Endoscopic Transhepatic Venous Access Needle (Class II - Special Controls, product code QIJ).
Submitted by Cook Ireland, Ltd. (Limerick, IE). The FDA issued a Not Cleared (DENG) decision on November 20, 2019.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.1050. An Endoscopic Transhepatic Venous Access Needle Is Inserted Through The Liver Into The Patients Portal/hepatic Venous System Under Endoscopic Ultrasound Guidance. It Is Connected To A Separate Device Intended To Measure A Physiological Parameter..
| 510(k) Number | DEN180062 FDA.gov |
| FDA Decision | Not Cleared Not Substantially Equivalent (DENG) |
| Date Received | November 19, 2018 |
| Decision Date | November 20, 2019 |
| Days to Decision | 366 days |
| Submission Type | Direct |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | — |
| Product Code | QIJ — Endoscopic Transhepatic Venous Access Needle |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.1050 |
| Definition | An Endoscopic Transhepatic Venous Access Needle Is Inserted Through The Liver Into The Patients Portal/hepatic Venous System Under Endoscopic Ultrasound Guidance. It Is Connected To A Separate Device Intended To Measure A Physiological Parameter. |