DeviceClearance

K894495

Substantially Equivalent

SURGITEK(R) EXTERNAL FILL PORT

Applicant
Surgitek
Product code
LCJ
Advisory panel
Unknown
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Racine, WI, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code LCJ

product code LCJ
Injury
2,704
Other
2
Total
2,706

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.