Data / Medical devices / United States / G-Surg Usa, Inc.
G-Surg Usa, Inc.: FDA-registered device maker in New York, NY, United States, 1 510(k) clearance
G-Surg Usa, Inc. is registered with the FDA (registration 3032855354) in New York, NY, United States. 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
- 3032855354
- Address
- 120 Wall St Fl 20, New York, NY, United States, 10005
- Owner or operator
- G-SURG USA, Inc. (10091642)
- Roles
- Complaint file establishment
- First device listed
- October 21, 2024
- Registered through
- 2026
- Brand names listed
- GERDX-Applicator, GERDX-Guide Wire, GERDX-Suture System, GERDX-System, GERDX-Tissue Retractor
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Endoscopic Suture/Plication System, Gastroesophageal Reflux Disease (Gerd) | ODE | 2 | Complaint file establishment | 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.