HALOFLEX ENERGY GENERATOR, MODELS 1190A-115A AND 1190A-230A
FDA 510(k) clearance K092487 · decided 2009-11-10
Clearance details
- K-number
- K092487
- Device name
- HALOFLEX ENERGY GENERATOR, MODELS 1190A-115A AND 1190A-230A
- Applicant
- Barrx Medical, Incorporated
- Decision
- Substantially Equivalent
- Date received
- 2009-08-13
- Decision date
- 2009-11-10
- Days to decision
- 89 days
- Clearance type
- Traditional
- Product code
- GEI
- Device class
- 2
- Regulation number
- 878.4400
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Sunnyvale, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| HALO Flex Energy Generators Manufactured by BRRX Medical (now Covidien) 540 Oakmead Parkwa recall (Z-2379-2012) | Covidien LLC | 2012-09-14 |