Gyrus G3 System (Generator, Assessories, Somnoplasty Electrodes and Plasmacision Electrodes)
FDA 510(k) K041285 · Gyrus Medical , Ltd.
510(k) numberK041285
Submission
- Device name
- Gyrus G3 System (Generator, Assessories, Somnoplasty Electrodes and Plasmacision Electrodes)
- Applicant
- Gyrus Medical , Ltd.
Cardiff, Wales, GB - Received
- May 13, 2004
- Decision date
- September 10, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- GEI – Electrosurgical, Cutting & Coagulation & Accessories
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4400
- Specialty
- General, Plastic Surgery
Validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission if the device is reusable and has specific design features (please refer to Table 2 of 82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
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| K050550 | Gyrus General Purpose Electrosurgical GeneratorGEI · Traditional | 11/09/2005SE |
| K050460 | Gyrus Plasmacision and Plasmablend ElectrodesGEI · Traditional | 10/25/2005SE |
| K041999 | Gyrus Plasma Skin Resurfacing SystemGEI · Traditional | 03/02/2005SE |
| K041633 | Gyrus Plasmacision Laparoscopic SpatulaGEI · Traditional | 10/22/2004SE |
| K024286 | Gyrus Open ForcepsGEI · Traditional | 11/17/2003SE |
| K031085 | Gyrus Plasmakinetic Superpulse System (Generator, Accessories)GEI · Traditional | 07/21/2003SE |
| K031082 | Everest Bipolar L Hook & PK Bipolar L HookGEI · Special | 05/21/2003SE |
| K031081 | Everest LP Bipolar Scissors and Gyrus LP Bipolar ScissorsGEI · Special | 05/21/2003SE |
| K031079 | Everest Bipolar Needle Electrode & Gyrus Bipolar Needle ElectrodeGEI · Special | 05/21/2003SE |
| K031080 | Everest Bipolar Lyons Dissecting Forceps & Gyrus Bipolar Lyons Dissecting ForcepsGEI · Special | 05/16/2003SE |
Questions and answers
When was Gyrus G3 System (Generator, Assessories, Somnoplasty Electrodes and Plasmacision Electrodes) cleared by the FDA?
Gyrus G3 System (Generator, Assessories, Somnoplasty Electrodes and Plasmacision Electrodes) (K041285) received a 510(k) decision of Substantially Equivalent on September 10, 2004, 120 days after the submission was received.
What is the product code of K041285?
The FDA product code is GEI – Electrosurgical, Cutting & Coagulation & Accessories, a Class II (moderate risk) device regulated under 21 CFR 878.4400.