EvoEndo Single-Use Endoscopy System— 510(k) K213606

Substantially Equivalent

EvoEndo, Inc.

FDA 510(k) clearance K213606 for EvoEndo Single-Use Endoscopy System, Substantially Equivalent on 2022-02-14. Applicant: EvoEndo, Inc..

Clearance details

Applicant: EvoEndo, Inc.
Product code: Code FDS
Advisory panel: Gastroenterology, Urology
Date received: 2021-11-15
Decision date: 2022-02-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Centennial, CO, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code FDS

product code FDS

Death: 37
Injury: 863
Malfunction: 56,442
Other: 1
Total: 57,343

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.