K260573
- 510(k) number
- K260573
- Device name
- EvoEndo Single-Use Endoscopy System
- Applicant
- EvoEndo, Inc. IL · US
- Product code
- FDS — Gastroscope And Accessories, Flexible/Rigid
- Decision date
- 2026-04-21
- Date received
- 2026-02-20
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 1.1 MB · U.S. public domain
Also available from FDA: K260573.pdf
Official FDA record: K260573
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.