DeviceClearance

K200090

Substantially Equivalent

PENTAX Medical EG-J10U Endoscopic Ultrasound System - EG34-J10U Ultrasound Upper GI Video Scope (Convex Array Type), EG36-J10UR Ultrasound Upper GI Video Scope (Radial Array Type), EG38-J10UT Ultrasound Upper GI Video Scope (Convex Array Type)

Applicant
Pentax of America, Inc.
Product code
ODG
Advisory panel
Gastroenterology, Urology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Montvale, NJ, US
Download summary PDF View on FDA.gov ↗

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, through . 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.