ACMI DUR-DIGITAL URETEROSCOPE AND CHOLEDOCHOSCOPE SYSTEM— 510(k) K060269

Substantially Equivalent

Acmi Corporation

FDA 510(k) clearance K060269 for ACMI DUR-DIGITAL URETEROSCOPE AND CHOLEDOCHOSCOPE SYSTEM, Substantially Equivalent on 2006-03-31. Applicant: Acmi Corporation.

Clearance details

Applicant: Acmi Corporation
Product code: Code FBN
Advisory panel: Gastroenterology, Urology
Date received: 2006-02-01
Decision date: 2006-03-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Southborough, MA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code FBN

product code FBN

Death: 8
Malfunction: 951
Total: 959

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.