PENTAX VIDEO COLONOSCOPES (EC FAMILY)— 510(k) K131855

Substantially Equivalent

Pentax Medical Company

FDA 510(k) clearance K131855 for PENTAX VIDEO COLONOSCOPES (EC FAMILY), Substantially Equivalent on 2014-04-09. Applicant: Pentax Medical Company.

Clearance details

Applicant: Pentax Medical Company
Product code: Code FDF
Advisory panel: Gastroenterology, Urology
Date received: 2013-06-21
Decision date: 2014-04-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Montvale, NJ, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code FDF

product code FDF

Death: 8
Injury: 729
Malfunction: 61,773
Total: 62,510

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.