DASH— 510(k) K071775

Substantially Equivalent

Ezsurgical

FDA 510(k) clearance K071775 for DASH, Substantially Equivalent on 2007-08-07. Applicant: Ezsurgical.

Clearance details

Applicant
Ezsurgical
Product code
Code GAD
Advisory panel
General, Plastic Surgery
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Littleton, CO, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code GAD

product code GAD
Malfunction
504
Total
504

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.