K180292

Substantially Equivalent

PENTAX Video Upper G.I. Scope EG34-i10

Applicant: Pentax Medical of America, Inc.
Product code: FDS
Advisory panel: Gastroenterology, Urology
Date received: 2018-02-01
Decision date: 2018-10-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Montvale, NJ, US

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.