De Novo
DEN250004: QIKCAP System
FDA De Novo · hai solutions · decided Dec 23, 2025
Key facts
| De Novo number | DEN250004 |
|---|---|
| Device name | QIKCAP System |
| Applicant | hai solutions |
| Product code | SGX |
| Date received | Jan 30, 2025 |
| Decision date | Dec 23, 2025 |
| Decision | granted (DENG) |
| FDA classification | Class II |
| Review panel | General Hospital |
| FEI number | 3043650423 |
At a glance
- None Later 510(k)s citing this De Novo
- None UDI device identifiers (GUDID)
- None 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: