K222856

Substantially Equivalent

SOMAVAC 100 Sustained Vacuum System

Applicant
Somavac Medical Solutions, Inc.
Product code
BTA
Advisory panel
General, Plastic Surgery
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Bartlett, TN, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code BTA

product code BTA
Death
5
Total
5

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.