K202365

Substantially Equivalent

Pentax Medical Video Duodenoscope ED32-i10

Applicant: Pentax of America, Inc.
Product code: FDT
Advisory panel: Gastroenterology, Urology
Date received: 2020-08-19
Decision date: 2021-04-01
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.