EvoEndo, Inc. - FDA 510(k) Cleared Devices

EvoEndo, Inc. develops single-use endoscopy systems for sedation-free procedures. The company specializes in ultra-slim, flexible scopes designed for patients of all ages, with a manufacturing facility in Centennial, Colorado. Its EvoEndo® Single-Use Endoscopy System enables both transnasal and transoral endoscopy without general anesthesia.

EvoEndo has received 4 FDA 510(k) clearances from 4 total submissions since its first clearance in 2022. All submissions focus on Gastroenterology & Urology devices. The company's latest clearance in 2026 reflects active development and ongoing market presence.

The EvoEndo System incorporates advanced features including four-way steering, portable imaging controllers, and virtual reality-based patient distraction. Clinical data reports a 98% procedure success rate and over 2,800 completed cases. The technology aligns with updated clinical guidelines for safer, more accessible endoscopic care, particularly in pediatric populations.

Explore the company's complete device portfolio, product codes, and clearance dates in the 510(k) database.

Regulatory submissions have been managed by AlvaMed, Inc. and Proxima Clinical Research.