DeviceClearance

K901182

Unknown

ENEMA BAG SET

Applicant
Orion Life Systems, Inc.
Product code
FCE
Advisory panel
Gastroenterology, Urology
Date received
Decision date
Decision
Unknown
Clearance type
Traditional
Location
Wheeling, IL, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code FCE

product code FCE
Other
2
Total
2

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.