K130247

Substantially Equivalent

PENTAX EG-3870UTK ULTRASOUND VIDEO GASTROSCOPE + HI VISION PREIRUS

Applicant: Pentax of America, Inc.
Product code: ODG
Advisory panel: Gastroenterology, Urology
Date received: 2013-02-01
Decision date: 2013-03-20
Decision: Substantially Equivalent
Clearance type: Special
Location: Montvale, NJ, US

Adverse events under product code ODG

product code ODG

Death: 30
Injury: 237
Malfunction: 12,387
Other: 1
Total: 12,655

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.