GIE MEDICAL
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| GIE MEDICAL | 5 | N | 2026-01-01 | 7601 Northland Dr N Ste 170 Brooklyn Park MN US 55428 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 351531 | 1634682159 | K253987 | BARE Wireguided Balloon Dilation Catheter (1235) | FGE | 2026-03-13 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| FGE | 1 | 2026-03-13 |