Clearance Summary
GERDX-System received FDA 510(k) clearance under submission number K233240, sponsored by G-Surg GmbH. The device was reviewed via the Traditional premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 2024-06-21.
- Submission: K233240
- Applicant / Sponsor: G-Surg GmbH
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1500
- Decision date: 2024-06-21
Classification & Regulation
This clearance is catalogued under FDA product code ODE and 21 CFR 876.1500, within the Gastroenterology, Urology review panel as a Class II device.