De Novo
DEN180062: EchoTip Insight Portosystemic Pressure Gradient Measuring System
FDA De Novo · cook ireland ltd. · decided Nov 20, 2019
Key facts
| De Novo number | DEN180062 |
|---|---|
| Device name | EchoTip Insight Portosystemic Pressure Gradient Measuring System |
| Applicant | cook ireland ltd. |
| Product code | QIJ |
| Date received | Nov 19, 2018 |
| Decision date | Nov 20, 2019 |
| Decision | granted (DENG) |
| FDA classification | Class II |
| Review panel | Gastroenterology & Urology |
| FEI number | 3001845648 |
At a glance
- None Later 510(k)s citing this De Novo
- 1–9 UDI device identifiers (GUDID)
- 1–9 MAUDE adverse event reports
- None Recall events
- No Decision summary on file
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About De Novo classification requests
The De Novo pathway classifies novel low- to moderate-risk devices that have no legally marketed predicate; each granted request creates a new classification regulation and product code.
Source: U.S. Food and Drug Administration (FDA), De Novo database · Source date: