GERDX-System— 510(k) K233240
Substantially EquivalentG-Surg GmbH
FDA 510(k) clearance K233240 for GERDX-System, Substantially Equivalent on 2024-06-21. Applicant: G-Surg GmbH. Device class: 2.
Clearance details
- Applicant
- G-Surg GmbH
- Product code
- Code ODE
- Device class
- Class 2
- Regulation
- 21 CFR 876.1500
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Seeon-Seebruck, DE
Recent devices under product code ODE
view all- K240879 — EsophyX Z+ Device with SerosaFuse Fasteners and Accessories
- K172811 — EsophyX Z, EsophyX2 HD
- K171307 — EsophyX2 HD Device with SerosaFuse Fasteners and Accessories, EsophyX Z Device with SerosaFuse Fasteners and Accessories
- K160960 — EsophyX® Z Device with SerosaFuse Fasteners and Accessories
- K151001 — MUSE System
Data sourced from openFDA. This site is unofficial and independent of the FDA.