Plasma Edge resection and vaporization electrodes, Plasma Edge working elements, Adaptor Plasma Edge
FDA 510(k) K213135 · Chirurgie Innovation
510(k) numberK213135
Submission
- Device name
- Plasma Edge resection and vaporization electrodes, Plasma Edge working elements, Adaptor Plasma Edge
- Applicant
- Chirurgie Innovation
Verrières Le Buisson, FR - Received
- September 27, 2021
- Decision date
- March 2, 2022
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FAS – Electrode, Electrosurgical, Active, Urological
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.4300
- Specialty
- Gastroenterology, Urology
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| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K251403 | Dornier Bi-Polar Electrode BIP12CLM Bipolar 12° Medium Cutting Loop 24 Fr…FAS · Traditional | Dornier Medtech America Inc (Dmta) | 12/05/2025SE |
| K250522 | Multi4 SystemFAS · Traditional | Multi4 Medical AB | 06/27/2025SE |
| K240504 | PLASMA EDGE SystemFAS · Special | Lamidey Noury Medical | 06/12/2024SE |
| K210651 | Resection Electrodes with HF cableFAS · Traditional | Olympus Winter & Ibe GmbH | 08/03/2021SE |
| K210394 | Electrosurgical accessoryFAS · Traditional | Dornier Medtech America, Inc. | 05/19/2021SE |
| K171965 | Resection Electrodes with HF cableFAS · Traditional | Olympus Winter & Ibe GmbH | 09/28/2017SE |
| K163090 | Plasma Edge SystemFAS · Traditional | Chirurgie Innovation | 05/23/2017SE |
| K151976 | Omnitech HF Resection Electrodes, Omnitech HF Vaporization ElectrodeFAS · Traditional | Omnitech Systems, Inc. | 06/27/2016SE |
| K152092 | Resection ElectrodesFAS · Traditional | Olympus Winter & Ibe GmbH | 10/26/2015SE |
| K120567 | Gyrus Amci PK Button ElectrodeFAS · Traditional | Gyrus Acmi, Inc. | 06/20/2012SE |
More from Gyrus Acmi, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K163090 | Plasma Edge SystemFAS · Traditional | 05/23/2017SE |
Questions and answers
When was Plasma Edge resection and vaporization electrodes, Plasma Edge working elements, Adaptor Plasma Edge cleared by the FDA?
Plasma Edge resection and vaporization electrodes, Plasma Edge working elements, Adaptor Plasma Edge (K213135) received a 510(k) decision of Substantially Equivalent on March 2, 2022, 156 days after the submission was received.
What is the product code of K213135?
The FDA product code is FAS – Electrode, Electrosurgical, Active, Urological, a Class II (moderate risk) device regulated under 21 CFR 876.4300.