K961897

Substantially Equivalent

WILSON-COOK BILIARY INTRODUCER WITH ASPIRATION BIOPSY NEEDLE

Applicant: Wilson-Cook Medical, Inc.
Product code: FCG
Advisory panel: Gastroenterology, Urology
Date received: 1996-05-16
Decision date: 1997-01-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Winston-Salem, NC, US

Adverse events under product code FCG

product code FCG

Death: 13
Injury: 576
Malfunction: 1,966
Total: 2,555

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.