Omnitech Fulgurating Electrode
FDA 510(k) K050454 · Omnitech Systems, Inc.
510(k) numberK050454
Submission
- Device name
- Omnitech Fulgurating Electrode
- Applicant
- Omnitech Systems, Inc.
Valparaiso, IN, US - Received
- February 22, 2005
- Decision date
- May 27, 2005
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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 |
More from Olympus Winter & Ibe GmbH
| 510(k) | Device | Decision |
|---|---|---|
| K151976 | Omnitech HF Resection Electrodes, Omnitech HF Vaporization ElectrodeFAS · Traditional | 06/27/2016SE |
| K981463 | Omnitech Resectoscope Roller ElectrodeKNF · Traditional | 07/17/1998SE |
| K981464 | Omnitech Resectoscope Cutting Loop ElectrodeKNF · Traditional | 07/10/1998SE |
| K964365 | Resectoscope Cutting Loop ElectrodeFAS · Traditional | 04/22/1997SE |
| K965093 | Omnitech Resectoscope Roller ElectrodeFAS · Traditional | 03/19/1997SE |
Questions and answers
When was Omnitech Fulgurating Electrode cleared by the FDA?
Omnitech Fulgurating Electrode (K050454) received a 510(k) decision of Substantially Equivalent on May 27, 2005, 94 days after the submission was received.
What is the product code of K050454?
The FDA product code is FAS – Electrode, Electrosurgical, Active, Urological, a Class II (moderate risk) device regulated under 21 CFR 876.4300.