PLASMA EDGE System
FDA 510(k) K240504 · Lamidey Noury Medical
510(k) numberK240504
Submission
- Device name
- PLASMA EDGE System
- Applicant
- Lamidey Noury Medical
Verrières Le Buisson, FR - Received
- February 21, 2024
- Decision date
- June 12, 2024
- 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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|---|---|---|---|
| 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 |
| 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 |
| 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 |
|---|---|---|
| K222542 | MCB UNIT Model: V10GMCBUSKNS · Traditional | 09/21/2022SE |
Questions and answers
When was PLASMA EDGE System cleared by the FDA?
PLASMA EDGE System (K240504) received a 510(k) decision of Substantially Equivalent on June 12, 2024, 112 days after the submission was received.
What is the product code of K240504?
The FDA product code is FAS – Electrode, Electrosurgical, Active, Urological, a Class II (moderate risk) device regulated under 21 CFR 876.4300.