HDE supplement
H040005 S014: FETOSCOPY INSTRUMENT SET
FDA HDE supplement · 30-day notice · KARL STORZ Endoscopy-America, Inc.
Key facts
| Original HDE | H040005 |
|---|---|
| Supplement number | S014 |
| Supplement type | 30-day notice |
| Reason for the supplement | process change - manufacturer/sterilizer/packager/supplier |
| Trade name | FETOSCOPY INSTRUMENT SET |
| Generic name | Amnioscope, transabdominal (fetoscope) (and accessories) |
| Applicant | KARL STORZ Endoscopy-America, Inc. |
| Product code | HFA |
| Received date | Sep 1, 2026 |
| Decision date | Oct 1, 2026 |
At a glance
- No Approval order on file
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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: