PENTAX EPK-I5020 VIDEO PROCESSOR— 510(k) K113873

Substantially Equivalent

Pentax of America, Inc.

FDA 510(k) clearance K113873 for PENTAX EPK-I5020 VIDEO PROCESSOR, Substantially Equivalent on 2012-06-22. Applicant: Pentax of America, Inc..

Clearance details

Applicant: Pentax of America, Inc.
Product code: Code FET
Advisory panel: Gastroenterology, Urology
Date received: 2011-12-30
Decision date: 2012-06-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: West Cadwell, NJ, US

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Adverse events under product code FET

product code FET

Injury: 313
Malfunction: 54,276
Total: 54,589

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.