K162128

Substantially Equivalent

Scope Buddy Plus Endoscope Flushing Aid

Applicant: Medivators, Inc.
Product code: FEB
Advisory panel: Gastroenterology, Urology
Date received: 2016-08-01
Decision date: 2016-12-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Minneapolis, MN, US

Adverse events under product code FEB

product code FEB

Malfunction: 3,879
Total: 3,879

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.