Plasma Edge System
FDA 510(k) K163090 · Chirurgie Innovation
510(k) numberK163090
Submission
- Device name
- Plasma Edge System
- Applicant
- Chirurgie Innovation
Massy, FR - Received
- November 4, 2016
- Decision date
- May 23, 2017
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
Device classification
- Product code
- FAS – Electrode, Electrosurgical, Active, Urological
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.4300
- Specialty
- Gastroenterology, Urology
Other 510(k)s with product code FAS
| 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 |
| K213135 | Plasma Edge resection and vaporization electrodes, Plasma Edge working elements, Adaptor…FAS · Special | Chirurgie Innovation | 03/02/2022SE |
| 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 |
| 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 |
|---|---|---|
| K213135 | Plasma Edge resection and vaporization electrodes, Plasma Edge working elements, Adaptor…FAS · Special | 03/02/2022SE |
Questions and answers
When was Plasma Edge System cleared by the FDA?
Plasma Edge System (K163090) received a 510(k) decision of Substantially Equivalent on May 23, 2017, 200 days after the submission was received.
What is the product code of K163090?
The FDA product code is FAS – Electrode, Electrosurgical, Active, Urological, a Class II (moderate risk) device regulated under 21 CFR 876.4300.