DeviceClearance

K820618

Substantially Equivalent

MICROSURGERY KNIFE

Applicant
Visitec Co.
Product code
HNN
Advisory panel
Ophthalmic
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Mchenry, IL, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code HNN

product code HNN
Injury
183
Malfunction
4,106
Total
4,289

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.