EvoEndo Single-Use Endoscopy System— 510(k) K260573
Substantially EquivalentEvoEndo, Inc.
FDA 510(k) clearance K260573 for EvoEndo Single-Use Endoscopy System, Substantially Equivalent on 2026-04-21. Applicant: EvoEndo, Inc.. Device class: 2.
Summary
EvoEndo's EvoEndo Single-Use Endoscopy System is filed under product code FDS (Gastroscope And Accessories, Flexible/Rigid).
Class II, 21 CFR 876.1500. It came in as a Traditional 510(k), and Gastroenterology and Urology is both the classification panel and the review panel.
EvoEndo filed from Grayslake, Illinois. Review took 60 calendar days (February 20 to April 21, 2026).
Clearance details
- Applicant
- EvoEndo, Inc.
- Product code
- Product code FDS
- Device class
- Class 2
- Regulation
- 21 CFR 876.1500
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Grayslake, IL, US
Recent devices under product code FDS
view allMore clearances from EvoEndo, Inc.
view allAdverse events under product code FDS
product code FDS- Death
- 37
- Injury
- 863
- Malfunction
- 56,442
- Other
- 1
- Total
- 57,343
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.