K250900
- 510(k) number
- K250900
- Device name
- EvoEndo Single-Use Endoscopy System
- Applicant
- EvoEndo, Inc. IL · US
- Product code
- FDS — Gastroscope And Accessories, Flexible/Rigid
- Decision date
- 2025-06-16
- Date received
- 2025-03-25
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
510(k) Summary (official FDA PDF): K250900.pdf
Official FDA record: K250900
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.