VEIN-GOGH INSTRUMENT
FDA 510(k) clearance K112334 · decided 2012-05-08
Clearance details
- K-number
- K112334
- Device name
- VEIN-GOGH INSTRUMENT
- Applicant
- Refine USA, LLC
- Decision
- Substantially Equivalent
- Date received
- 2011-08-12
- Decision date
- 2012-05-08
- Days to decision
- 270 days
- Clearance type
- Traditional
- Product code
- ONQ
- Device class
- 2
- Regulation number
- 878.4400
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Jacksonville Beach, FL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| MED RF 4000 (K210077) | F Care Systems USA, LLC | 2021-12-17 |
| EVRF SYSTEM (K130283) | F Care Systems NV | 2013-03-07 |
| VEINWAVE, TC3000 (K083352) | Newlands Clinical Trials, Ltd. | 2009-06-12 |
Recalls involving this device
No recalls on record reference this clearance.