PENTAX Medical Video Duedenoscope ED34-i10T2— 510(k) K210710

Substantially Equivalent

Pentax of America, Inc.

FDA 510(k) clearance K210710 for PENTAX Medical Video Duedenoscope ED34-i10T2, Substantially Equivalent on 2021-04-09. Applicant: Pentax of America, Inc..

Clearance details

Applicant: Pentax of America, Inc.
Product code: Code FDT
Advisory panel: Gastroenterology, Urology
Date received: 2021-03-10
Decision date: 2021-04-09
Decision: Substantially Equivalent
Clearance type: Special
Location: Montvale, NJ, US

Download summary PDF View on FDA.gov ↗

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.