HDE
H150003: Flourish Pediatric Esophageal Atresia Anastomosis Device
FDA Humanitarian Device Exemption · WILSON-COOK MEDICAL INC.
Key facts
| HDE number | H150003 |
|---|---|
| Trade name | Flourish Pediatric Esophageal Atresia Anastomosis Device |
| Generic name | Pediatric esophageal atresia anastomosis device |
| Applicant | WILSON-COOK MEDICAL INC. |
| Owner/operator | COOK ENDOSCOPY |
| Product code | PTK |
| Approval date | May 12, 2017 |
| Docket number | 17M-3103 |
| Notice date | May 17, 2017 |
| Establishment registration | 1037905 |
| FEI number | 1037905 |
At a glance
- 1–9 Supplements
- Nov 3, 2022 Latest supplement decision
- Yes Summary of safety and probable benefit on file
- 1–9 UDI device identifiers (GUDID)
- 10–99 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: