HALO360 ENERGY GENERATOR, MODELS 1100C-115B AND 1100C-230B— 510(k) K082202
Substantially EquivalentBarrx Medical, Incorporated
FDA 510(k) clearance K082202 for HALO360 ENERGY GENERATOR, MODELS 1100C-115B AND 1100C-230B, Substantially Equivalent on 2008-10-08. Applicant: Barrx Medical, Incorporated.
Clearance details
- Applicant
- Barrx Medical, Incorporated
- Product code
- Code GEI
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Sunnyvale, CA, US
Adverse events under product code GEI
product code GEI- Death
- 133
- Injury
- 7,585
- Malfunction
- 35,808
- Other
- 44
- Total
- 43,570
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.