K892549

Substantially Equivalent

SUCTION TUBES: HOUSE, BARON

Applicant
Zinnanti Surgical Instruments, Inc.
Product code
GCX
Advisory panel
General Hospital
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Chatsworth, CA, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code GCX

product code GCX
Death
9
Malfunction
592
Other
2
Total
603

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.