HDE
H040005: FETOSCOPY INSTRUMENT SET
FDA Humanitarian Device Exemption · KARL STORZ ENDOSCOPY-AMERICA, INC.
Key facts
| HDE number | H040005 |
|---|---|
| Trade name | FETOSCOPY INSTRUMENT SET |
| Generic name | Amnioscope, transabdominal (fetoscope) (and accessories) |
| Applicant | KARL STORZ ENDOSCOPY-AMERICA, INC. |
| Owner/operator | KARL STORZ SE & CO KG |
| Product code | HFA |
| Approval date | Mar 31, 2006 |
| Docket number | 06M0163 |
| Notice date | Apr 21, 2006 |
| Establishment registration | 3010202439 |
| FEI number | 3007475226 |
At a glance
- 10–99 Supplements
- Oct 1, 2026 Latest supplement decision
- Yes Summary of safety and probable benefit on file
- None UDI device identifiers (GUDID)
- 1–9 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: