GYRUS G3 SYSTEM (GENERATOR, ASSESSORIES, SOMNOPLASTY ELECTRODES AND PLASMACISION ELECTRODES)
FDA 510(k) clearance K041285 · decided 2004-09-10
Clearance details
- K-number
- K041285
- Device name
- GYRUS G3 SYSTEM (GENERATOR, ASSESSORIES, SOMNOPLASTY ELECTRODES AND PLASMACISION ELECTRODES)
- Applicant
- Gyrus Medical , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2004-05-13
- Decision date
- 2004-09-10
- Days to decision
- 120 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
- Cardiff, Wales, GB
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| GYRUS ACMI, dissector PlasmaKnife" , REF 7035-3005, Rx only, STERILE R, CE 0344, 161416-CA recall (Z-2651-2010) | Gyrus Acmi, Incorporated | 2010-09-30 |
| Gyrus ACMI, Inc. dissector PlasmaKnife (DPK) Catalog No: 7035-3005 A single use only bipol recall (Z-0273-2009) | Gyrus ACMI Corporation | 2008-11-05 |