DeviceClearance

K993242

Substantially Equivalent

CASTLE SURGICAL LIGHT, MODEL 3000

Applicant
Getinge/Castle, Inc.
Product code
FSY
Advisory panel
General, Plastic Surgery
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
North Charleston, SC, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code FSY

product code FSY
Malfunction
2,759
Other
1
Total
2,760

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.