K240879
- 510(k) number
- K240879
- Device name
- EsophyX Z+ Device with SerosaFuse Fasteners and Accessories
- Applicant
- Endogastric Solutions, Inc. WA · US
- Product code
- ODE — Endoscopic Suture/Plication System, Gastroesophageal
- Decision date
- 2024-04-26
- Date received
- 2024-03-29
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 1.0 MB · U.S. public domain
Also available from FDA: K240879.pdf
Official FDA record: K240879
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.