PLASMAJET NEUTRAL PLASMA SURGERY SYSTEM
FDA 510(k) clearance K080197 · decided 2008-06-24
Clearance details
- K-number
- K080197
- Device name
- PLASMAJET NEUTRAL PLASMA SURGERY SYSTEM
- Applicant
- Plasma Surgical, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2008-01-25
- Decision date
- 2008-06-24
- Days to decision
- 151 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
- Theale, Berkshire, GB
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| PlasmaJet Open Surgery Handpiece (Part of the PlasmaJet Neutral Plasma Surgery System) The recall (Z-1794-2012) | Plasma Surgical Inc. | 2012-06-11 |