PENTAX EPK-I5010 VIDEO PROCESSOR— 510(k) K122470

Substantially Equivalent

Pentax Medical

FDA 510(k) clearance K122470 for PENTAX EPK-I5010 VIDEO PROCESSOR, Substantially Equivalent on 2013-04-10. Applicant: Pentax Medical.

Clearance details

Applicant: Pentax Medical
Product code: Code PEA
Advisory panel: Gastroenterology, Urology
Date received: 2012-08-13
Decision date: 2013-04-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Montvale, NJ, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code PEA

product code PEA

Malfunction: 515
Total: 515

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.