FAS — Electrode, Electrosurgical, Active, Urological Class II
FDA product code FAS covers "Electrode, Electrosurgical, Active, Urological", a Class II medical device regulated under 21 CFR 876.4300. Submissions are reviewed by the Gastroenterology, Urology panel. At least 20 recent 510(k) clearances have been granted under this product code.
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 |