FAS — Electrode, Electrosurgical, Active, Urological Class II
FDA Device Classification
Classification Details
- Product Code
- FAS
- Device Class
- Class II
- Regulation Number
- 876.4300
- Submission Type
- Review Panel
- GU
- Medical Specialty
- Gastroenterology, Urology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K251403 | dornier medtech america inc (dmta) | Dornier Bi-Polar Electrode BIP12CLM Bipolar 12° Medium Cutting Loop 24 Fr Elect | December 5, 2025 |
| K250522 | multi4 medical | Multi4 System | June 27, 2025 |
| K240504 | lamidey noury medical | PLASMA EDGE System | June 12, 2024 |
| K213135 | chirurgie innovation | Plasma Edge resection and vaporization electrodes, Plasma Edge working elements, | March 2, 2022 |
| K210651 | olympus winter and ibe | Resection Electrodes with HF cable | August 3, 2021 |
| K210394 | dornier medtech america | Electrosurgical accessory | May 19, 2021 |
| K171965 | olympus winter and ibe | Resection Electrodes with HF cable | September 28, 2017 |
| K163090 | chirurgie innovation | Plasma Edge System | May 23, 2017 |
| K151976 | omnitech systems | Omnitech HF Resection Electrodes, Omnitech HF Vaporization Electrode | June 27, 2016 |
| K152092 | olympus winter and ibe | Resection Electrodes | October 26, 2015 |
| K120567 | gyrus acmi | GYRUS AMCI PK BUTTON ELECTRODE | June 20, 2012 |
| K120418 | olympus winter and ibe | ELECTROSUGRICAL RESECTION AND VAPORIZATION ELECTRODE SERIES | June 20, 2012 |
| K102781 | olympus winter and ibe | RESECTION BUTTON ELECTRODE FOR PLASMA VAPORIZATION, HF-RESECTION ELECTRODE ROLLE | January 11, 2011 |
| K100275 | olympus winter and ibe | WORKING ELEMENT, RESECTION BUTTON ELECTRODE FOR PLASMA VAPORIZATON, HF-RESECTION | July 1, 2010 |
| K093181 | gyrus acmi | GYRUS ACMI PK BUTTON ELECTRODE | February 24, 2010 |
| K091511 | modern medical equipment mfg | MODERN MEDICAL RESECTOSCOPE ELECTRODES | January 15, 2010 |
| K061541 | ksea | KSEA BIPOLAR ELECTROTOME | August 21, 2006 |
| K053322 | roei medical technologies | MODIFICATION TO: ROEI WORKING ELEMENT AND ROEI CUTTING LOOPS | January 6, 2006 |
| K050910 | roei medical technologies | ROEI WORKING ELEMENT AND ROEL CUTTING LOOPS | June 16, 2005 |
| K050454 | omnitech systems | OMNITECH FULGURATING ELECTRODE | May 27, 2005 |