BLUESKY VISTA WOUND VACUUM SYSTEM, MODEL 100.0500— 510(k) K061367
Substantially EquivalentBlue Sky Medical Group Incorporated
FDA 510(k) clearance K061367 for BLUESKY VISTA WOUND VACUUM SYSTEM, MODEL 100.0500, Substantially Equivalent on 2006-08-10. Applicant: Blue Sky Medical Group Incorporated.
Clearance details
- Applicant
- Blue Sky Medical Group Incorporated
- Product code
- Code OMP
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Carlsbad, CA, US
Adverse events under product code OMP
product code OMP- Death
- 31
- Injury
- 1,707
- Malfunction
- 4,047
- Other
- 1
- Total
- 5,786
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.