K900923

Substantially Equivalent

ZIMMON ENDOSCOPIC PANCREATIC STENT

Applicant: Wilson-Cook Medical, Inc.
Product code: FGE
Advisory panel: Gastroenterology, Urology
Date received: 1990-02-27
Decision date: 1990-10-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Winston-Salem, NC, US

Adverse events under product code FGE

product code FGE

Death: 52
Injury: 2,347
Malfunction: 9,798
Other: 1
Total: 12,198

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.