Electrosugrical Resection and Vaporization Electrode Series
FDA 510(k) K120418 · Olympus Winter & Ibe GmbH
510(k) numberK120418
Submission
- Device name
- Electrosugrical Resection and Vaporization Electrode Series
- Applicant
- Olympus Winter & Ibe GmbH
Center Valley, PA, US - Received
- February 10, 2012
- Decision date
- June 20, 2012
- 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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| 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 |
| 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 |
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| K231777 | Electrosurgical Generator ESG-410 and Accessories (WA91327U, WA91327W), Accessories:…GEI · Traditional | 08/18/2023SE |
| K221522 | HF-cables (resusable)GEI · Traditional | 01/19/2023SE |
| K223183 | Light-Guide CablesHBI · Traditional | 01/13/2023SE |
| K213207 | Sheath, Stopcock AccessoryHIH · Traditional | 12/22/2021SE |
| K203492 | Instrument tray, for semi-rigid ureteroscopeKCT · Traditional | 09/15/2021SE |
| K210651 | Resection Electrodes with HF cableFAS · Traditional | 08/03/2021SE |
| K203682 | Electrosurgical Generator ESG-400, Foot Switches, POWERSEAL Curved Jaw Sealer and…GEI · Traditional | 05/17/2021SE |
| K203277 | Electrosurgical Generator ESG-410, Foot Switches, PK Cutting ForcepsGEI · Traditional | 04/28/2021SE |
Questions and answers
When was Electrosugrical Resection and Vaporization Electrode Series cleared by the FDA?
Electrosugrical Resection and Vaporization Electrode Series (K120418) received a 510(k) decision of Substantially Equivalent on June 20, 2012, 131 days after the submission was received.
What is the product code of K120418?
The FDA product code is FAS – Electrode, Electrosurgical, Active, Urological, a Class II (moderate risk) device regulated under 21 CFR 876.4300.