GENICON CLIP APPLIER— 510(k) K030269

Substantially Equivalent

Genicon, LC

FDA 510(k) clearance K030269 for GENICON CLIP APPLIER, Substantially Equivalent on 2003-03-20. Applicant: Genicon, LC.

Clearance details

Applicant
Genicon, LC
Product code
Code FZP
Advisory panel
General, Plastic Surgery
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Orlando, FL, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code FZP

product code FZP
Death
11
Injury
726
Malfunction
10,830
Other
1
Total
11,568

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.