Data / Medical devices / United States / Gie Medical
Gie Medical: FDA-registered device maker in Brooklyn Park, MN, United States, 1 510(k) clearance
Gie Medical is registered with the FDA (registration 3031230150) in Brooklyn Park, MN, United States. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated March 13, 2026. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3031230150
- Address
- 7601 Northland Dr N Ste 170, Brooklyn Park, MN, United States, 55428
- Owner or operator
- GIE Medical (10096038)
- Roles
- Manufacturer
- First device listed
- June 11, 2026
- Registered through
- 2026
- Brand names listed
- BARE Wireguided Balloon Dilation Catheter
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Dilator, Esophageal | KNQ | 2 | Manufacturer | accessdata.fda.gov |
| Stents, Drains And Dilators For The Biliary Ducts | FGE | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| March 13, 2026 | K253987 | BARE Wireguided Balloon Dilation Catheter (1235) | FGE | Substantially Equivalent | GIE Medical | accessdata.fda.gov |
Compare with other makers
Updated March 13, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.