Data / Medical devices / Netherlands / Gore European Warehouse Support
Gore European Warehouse Support: FDA-registered device maker in Tilburg Noord-Brabant, Netherlands, 3 510(k) clearances
Gore European Warehouse Support is registered with the FDA (registration 3015138222) in Tilburg Noord-Brabant, Netherlands. It lists 2 device types. The FDA files 3 510(k) clearances under its listings, the newest dated January 31, 2018. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3015138222
- Address
- Doctor Paul Janssenweg 150, Tilburg Noord-Brabant, Netherlands, 5026
- Owner or operator
- W. L. GORE & ASSOCIATES, INC. (9925013)
- Roles
- Exporter to the US
- First device listed
- May 13, 2016
- Registered through
- 2027
- Brand names listed
- GORE TIPS Set, GORE® DrySeal Flex Introducer Sheath, GORE® Molding and Occlusion Balloon Catheter
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Catheter, Intravascular Occluding, Temporary | MJN | 2 | Exporter to the US | accessdata.fda.gov |
| Introducer, Catheter | DYB | 2 | Exporter to the US | 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 |
|---|---|---|---|---|---|---|
| January 31, 2018 | K172567 | GORE Molding and Occlusion Balloon Catheter | MJN | Substantially Equivalent | W. L. Gore and Associates, Inc. | accessdata.fda.gov |
| July 21, 2016 | K152913 | GORE TIPS Set, GORE TIPS Sheath, GORE TIPS Needle | DYB | Substantially Equivalent | Creganna Medical Aslo Business AS Cregganna Tactx Medical | accessdata.fda.gov |
| May 12, 2016 | K160254 | GORE DrySeal Flex Introducer Sheath | DYB | Substantially Equivalent | W. L. Gore & Associates, Inc. | accessdata.fda.gov |
Compare with other makers
Updated January 31, 2018. 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.