3.5 MM SIDE EFFECT ELECTRODE WITH INTEGRATED HANDPIECE, MODEL 227301, 3.5 MM ANGLED SIDE EFFECT ELECTRODE WITH INTEGRATE
FDA 510(k) clearance K082643 · decided 2008-12-19
Clearance details
- K-number
- K082643
- Device name
- 3.5 MM SIDE EFFECT ELECTRODE WITH INTEGRATED HANDPIECE, MODEL 227301, 3.5 MM ANGLED SIDE EFFECT ELECTRODE WITH INTEGRATE
- Applicant
- Depuy Mitek, A Johnson & Johnson Company
- Decision
- Substantially Equivalent
- Date received
- 2008-09-11
- Decision date
- 2008-12-19
- Days to decision
- 99 days
- Clearance type
- Special
- Product code
- GEI
- Device class
- 2
- Regulation number
- 878.4400
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Raynham, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| DePuy Mitek VAPR Hook Electrode 3.5mm Hook Electrode with Integrated Handpiece Catalog Num recall (Z-0133-2013) | DePuy Mitek, Inc., a Johnson & Johnson Co. | 2012-10-24 |
| Mitek VAPR Side Effect Electrode (integrated) Product Code: 227301 The VAPR Electrodes (en recall (Z-2301-2010) | DePuy Mitek, Inc., a Johnson & Johnson Co. | 2010-08-27 |