REYNOLDS DOUBLE HEMOCLIP APPLIERS— 510(k) K790990

Substantially Equivalent

Edward Weck, Inc.

FDA 510(k) clearance K790990 for REYNOLDS DOUBLE HEMOCLIP APPLIERS, Substantially Equivalent on 1979-06-05. Applicant: Edward Weck, Inc..

Clearance details

Applicant
Edward Weck, Inc.
Product code
Code GDO
Advisory panel
General, Plastic Surgery
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Mchenry, IL, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code GDO

product code GDO
Death
5
Malfunction
2,124
Total
2,129

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.