510(k) K130206— PENTAX EG-3670URK ULTRASOUND VIDEO GASTROSCOPE + HI VISION PREIRUS

Substantially Equivalent

Pentax of America, Inc.

Clearance details

Applicant: Pentax of America, Inc.
Product code: Code ODG
Advisory panel: Gastroenterology, Urology
Date received: 2013-01-28
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.