HDE
H200002: OncoSil™
FDA Humanitarian Device Exemption · OncoSil Medical USA, Inc.
Key facts
| HDE number | H200002 |
|---|---|
| Trade name | OncoSil™ |
| Generic name | P-32 microparticle for distal cholangiocarcinoma intratumoral injection |
| Applicant | OncoSil Medical USA, Inc. |
| Product code | SIY |
| Approval date | Aug 14, 2026 |
| Docket number | FDA-9373 |
| Notice date | Aug 18, 2026 |
At a glance
- None Supplements
- Aug 14, 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: