DeviceClearance

XENOMEM WOUND MATRIX— 510(k) K140820

Substantially Equivalent

Viscus Biologics, LLC

FDA 510(k) clearance K140820 for XENOMEM WOUND MATRIX, Substantially Equivalent on 2015-06-26. Applicant: Viscus Biologics, LLC.

Clearance details

Applicant
Viscus Biologics, LLC
Product code
Code KGN
Advisory panel
Unknown
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Stillwater, MN, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code KGN

product code KGN
Other
2
Total
2

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.