Data / Medical devices / Belgium / G-Flex Europe SRL
G-Flex Europe SRL: FDA-registered device maker in Nivelles Brabant Wallon, Belgium, 1 510(k) clearance
G-Flex Europe SRL is registered with the FDA (registration 3008274780) in Nivelles Brabant Wallon, Belgium. It lists 5 device types. The FDA files 1 510(k) clearance under its listings, the newest dated April 3, 2023. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3008274780
- Address
- 20 Rue de l'Industrie, Nivelles Brabant Wallon, Belgium, 1400
- Owner or operator
- G-flex Europe Srl (10082053)
- Roles
- Specification developer
- First device listed
- June 10, 2021
- Registered through
- 2027
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Endoscopic Guidewire, Gastroenterology-Urology | OCY | 2 | Specification developer | accessdata.fda.gov |
| Endoscopic Injection Needle, Gastroenterology-Urology | FBK | 2 | Specification developer | accessdata.fda.gov |
| Forceps, Biopsy, Non-Electric | FCL | 1 | Specification developer | accessdata.fda.gov |
| Ligator, Esophageal | MND | 2 | Specification developer | accessdata.fda.gov |
| Ligator, Hemorrhoidal | FHN | 2 | Specification developer | 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 |
|---|---|---|---|---|---|---|
| April 3, 2023 | K222006 | Sclerotherapy & Endoscopic Needles | FBK | Substantially Equivalent | G-Flex Europe Sprl | accessdata.fda.gov |
Compare with other makers
- All makers of Endoscopic Injection Needle, Gastroenterology-Urology
- All makers of Endoscopic Guidewire, Gastroenterology-Urology
- All makers of Forceps, Biopsy, Non-Electric
- All makers of Ligator, Hemorrhoidal
- All makers of Ligator, Esophageal
Updated April 3, 2023. 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.