HDE
H230002: River Stent System™
FDA Humanitarian Device Exemption · Serenity Medical, Inc.
Key facts
| HDE number | H230002 |
|---|---|
| Trade name | River Stent System™ |
| Generic name | Intracranial neurovascular stent |
| Applicant | Serenity Medical, Inc. |
| Product code | NJE |
| Approval date | Mar 30, 2026 |
At a glance
- None Supplements
- Mar 30, 2026 Latest supplement decision
- Yes Summary of safety and probable benefit on file
- None UDI device identifiers (GUDID)
- None MAUDE adverse event reports
- None Recall events
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About HDE approvals
A Humanitarian Device Exemption (HDE) authorizes devices intended to benefit patients with rare diseases or conditions affecting small populations in the United States.
Source: U.S. Food and Drug Administration (FDA), Humanitarian Device Exemption (HDE) database · Source date: