DEDO SUCTION CANNULA— 510(k) K854005

Substantially Equivalent for Some Indications

Dedo Manufacturer, Inc.

FDA 510(k) clearance K854005 for DEDO SUCTION CANNULA, Substantially Equivalent for Some Indications on 1985-12-06. Applicant: Dedo Manufacturer, Inc..

Clearance details

Applicant
Dedo Manufacturer, Inc.
Product code
Code GEA
Advisory panel
General, Plastic Surgery
Date received
Decision date
Decision
Substantially Equivalent for Some Indications
Clearance type
Traditional
Location
West Palm Beach, 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.