HDE supplement
H040005 S008: Fetoscopy Instruments
FDA HDE supplement · normal 75 day track · KARL STORZ ENDOSCOPY-AMERICA, INC.
Key facts
| Original HDE | H040005 |
|---|---|
| Supplement number | S008 |
| Supplement type | normal 75 day track |
| Reason for the supplement | process change - manufacturer/sterilizer/packager/supplier |
| Trade name | Fetoscopy Instruments |
| Generic name | Amnioscope, transabdominal (fetoscope) (and accessories) |
| Applicant | KARL STORZ ENDOSCOPY-AMERICA, INC. |
| Product code | HFA |
| Received date | Jan 21, 2022 |
| Decision date | Apr 4, 2022 |
At a glance
- No Approval order on file
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About HDE supplements
An HDE supplement asks FDA to approve a change to a Humanitarian Use Device that already holds a humanitarian device exemption.
Source: U.S. Food and Drug Administration (FDA), Humanitarian Device Exemption (HDE) database · Source date: