SOMAVAC® 100 Sustained Vacuum System— 510(k) K231063
Substantially EquivalentSomavac Medical Solutions, Inc.
FDA 510(k) clearance K231063 for SOMAVAC® 100 Sustained Vacuum System, Substantially Equivalent on 2023-05-12. Applicant: Somavac Medical Solutions, Inc..
Clearance details
- Applicant
- Somavac Medical Solutions, Inc.
- Product code
- Code BTA
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Bartlett, TN, US
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.