Gyrus Plasmakinetic Superpulse System (Generator, Accessories)
FDA 510(k) K031085 · Gyrus Medical, Inc.
510(k) numberK031085
Submission
- Device name
- Gyrus Plasmakinetic Superpulse System (Generator, Accessories)
- Applicant
- Gyrus Medical, Inc.
Maple Grove, MN, US - Received
- April 4, 2003
- Decision date
- July 21, 2003
- 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 |
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| K041285 | Gyrus G3 System (Generator, Assessories, Somnoplasty Electrodes and Plasmacision…GEI · Traditional | 09/10/2004SE |
| K024286 | Gyrus Open ForcepsGEI · Traditional | 11/17/2003SE |
| K031082 | Everest Bipolar L Hook & PK Bipolar L HookGEI · Special | 05/21/2003SE |
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| 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 Plasmakinetic Superpulse System (Generator, Accessories) cleared by the FDA?
Gyrus Plasmakinetic Superpulse System (Generator, Accessories) (K031085) received a 510(k) decision of Substantially Equivalent on July 21, 2003, 108 days after the submission was received.
What is the product code of K031085?
The FDA product code is GEI – Electrosurgical, Cutting & Coagulation & Accessories, a Class II (moderate risk) device regulated under 21 CFR 878.4400.