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 | Dec 5, 2025 |
| K250522 | Multi4 Medical | Multi4 System | Jun 27, 2025 |
| K240504 | Lamidey Noury Medical | PLASMA EDGE System | Jun 12, 2024 |
| K213135 | Chirurgie Innovation | Plasma Edge resection and vaporization electrodes, Plasma Edge working elements, | Mar 2, 2022 |
| K210651 | Olympus Winter And Ibe | Resection Electrodes with HF cable | Aug 3, 2021 |
| K210394 | Dornier Medtech America | Electrosurgical accessory | May 19, 2021 |
| K171965 | Olympus Winter And Ibe | Resection Electrodes with HF cable | Sep 28, 2017 |
| K163090 | Chirurgie Innovation | Plasma Edge System | May 23, 2017 |
| K151976 | Omnitech Systems | Omnitech HF Resection Electrodes, Omnitech HF Vaporization Electrode | Jun 27, 2016 |
| K152092 | Olympus Winter And Ibe | Resection Electrodes | Oct 26, 2015 |
| K120567 | Gyrus Acmi | GYRUS AMCI PK BUTTON ELECTRODE | Jun 20, 2012 |
| K120418 | Olympus Winter And Ibe | ELECTROSUGRICAL RESECTION AND VAPORIZATION ELECTRODE SERIES | Jun 20, 2012 |
| K102781 | Olympus Winter And Ibe | RESECTION BUTTON ELECTRODE FOR PLASMA VAPORIZATION, HF-RESECTION ELECTRODE ROLLE | Jan 11, 2011 |
| K100275 | Olympus Winter And Ibe | WORKING ELEMENT, RESECTION BUTTON ELECTRODE FOR PLASMA VAPORIZATON, HF-RESECTION | Jul 1, 2010 |
| K093181 | Gyrus Acmi | GYRUS ACMI PK BUTTON ELECTRODE | Feb 24, 2010 |
| K091511 | Modern Medical Equipment Mfg | MODERN MEDICAL RESECTOSCOPE ELECTRODES | Jan 15, 2010 |
| K061541 | Ksea | KSEA BIPOLAR ELECTROTOME | Aug 21, 2006 |
| K053322 | Roei Medical Technologies | MODIFICATION TO: ROEI WORKING ELEMENT AND ROEI CUTTING LOOPS | Jan 6, 2006 |
| K050910 | Roei Medical Technologies | ROEI WORKING ELEMENT AND ROEL CUTTING LOOPS | Jun 16, 2005 |
| K050454 | Omnitech Systems | OMNITECH FULGURATING ELECTRODE | May 27, 2005 |