GENICON TROCAR— 510(k) K982472

Substantially Equivalent

Genicon, LC

FDA 510(k) clearance K982472 for GENICON TROCAR, Substantially Equivalent on 1999-02-04. Applicant: Genicon, LC.

Clearance details

Applicant
Genicon, LC
Product code
Code GEA
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 GEA

product code GEA
Malfunction
587
Total
587

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.