DeviceClearance

K001807

Substantially Equivalent

TISSUE MARKER

Applicant
Advanced Uroscience, Inc.
Product code
GDW
Advisory panel
General, Plastic Surgery
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
St. Paul, MN, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code GDW

product code GDW
Death
450
Injury
12,684
Malfunction
68,730
Other
6
Total
81,870

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.