K233240
- 510(k) number
- K233240
- Device name
- GERDX-System
- Applicant
- G-Surg GmbH DE
- Product code
- ODE — Endoscopic Suture/Plication System, Gastroesophageal
- Decision date
- 2024-06-21
- Date received
- 2023-09-28
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 0.9 MB · U.S. public domain
Also available from FDA: K233240.pdf
Official FDA record: K233240
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.