DeviceClearance

K013737

Substantially Equivalent

MODIFICATION TO: 3-LUMEN DURALON OCCLUSION BALLOON

Applicant
Telemed Systems, Inc.
Product code
FGE
Advisory panel
Gastroenterology, Urology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Hudson, MA, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code FGE

product code FGE
Death
52
Injury
2,347
Malfunction
9,798
Other
1
Total
12,198

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.