PENTAX Medical Video Upper GI Scopes (EG Family)— 510(k) K190799

Substantially Equivalent

Pentax of America, Inc.

FDA 510(k) clearance K190799 for PENTAX Medical Video Upper GI Scopes (EG Family), Substantially Equivalent on 2019-11-12. Applicant: Pentax of America, Inc..

Clearance details

Applicant: Pentax of America, Inc.
Product code: Code FDS
Advisory panel: Gastroenterology, Urology
Date received: 2019-03-28
Decision date: 2019-11-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Montvale, NJ, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code FDS

product code FDS

Death: 37
Injury: 863
Malfunction: 56,442
Other: 1
Total: 57,343

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.