Data / Medical devices / Germany / G-Surg GMBH
G-Surg GMBH: FDA-registered device maker in Seeon-Seebruck Bavaria, Germany, 1 510(k) clearance
G-Surg GMBH is registered with the FDA (registration 3033508651) in Seeon-Seebruck Bavaria, Germany. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated June 21, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3033508651
- Address
- Weinbergstrasse 28, Seeon-Seebruck Bavaria, Germany, 83370
- Owner or operator
- G-SURG GmbH (10091470)
- Roles
- Manufacturer
- First device listed
- October 7, 2024
- Registered through
- 2026
- Brand names listed
- GERDX - Applicator, GERDX - Guide Wire, GERDX - Implant System, GERDX - Suture System, GERDX - Tissue Retractor
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Endoscopic Suture/Plication System, Gastroesophageal Reflux Disease (Gerd) | ODE | 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 |
|---|---|---|---|---|---|---|
| June 21, 2024 | K233240 | GERDX-System | ODE | Substantially Equivalent | G-Surg GmbH | accessdata.fda.gov |
Updated June 21, 2024. 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.