K092710

Substantially Equivalent

PENTAX ED-3490TK, VIDEO DUODENOSCOPE

Applicant: Pentax Medical Company
Product code: FDT
Advisory panel: Gastroenterology, Urology
Date received: 2009-09-03
Decision date: 2009-12-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Montvale, NJ, US

Adverse events under product code FDT

product code FDT

Death: 86
Injury: 1,954
Malfunction: 14,912
Total: 16,952

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.