510(k) K954745— MILL-ROSE RIGID SCOPE CLEANING BRUSHES

Substantially Equivalent

Mill-Rose Laboratory

Clearance details

Applicant: Mill-Rose Laboratory
Product code: Code FEB
Advisory panel: Gastroenterology, Urology
Date received: 1995-10-16
Decision date: 1995-11-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mentor, OH, 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.