FAS · Electrode, Electrosurgical, Active, Urological
Gastroenterology, Urology · 21 CFR 876.4300 · Class 2
Overview
| Product Code | FAS |
|---|---|
| Device Name | Electrode, Electrosurgical, Active, Urological |
| Regulation | 21 CFR 876.4300 |
| Device Class | Class 2 |
| Review Panel | Gastroenterology, Urology |
| 3rd-Party Reviewable | Yes |
Identification
An endoscopic electrosurgical unit and accessories is a device used to perform electrosurgical procedures through an endoscope. This generic type of device includes the electrosurgical generator, patient plate, electric biopsy forceps, electrode, flexible snare, electrosurgical alarm system, electrosurgical power supply unit, electrical clamp, self-opening rigid snare, flexible suction coagulator electrode, patient return wristlet, contact jelly, adaptor to the cord for transurethral surgical instruments, the electric cord for transurethral surgical instruments, and the transurethral desiccator.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (20 of 58)
Showing 20 most recent of 58 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K251403 | Dornier Bi-Polar Electrode BIP12CLM Bipolar 12° Medium Cutting Loop 24 Fr Electrode-Sterile, Single-Use BIP12CLL Bipolar 12° Large Cutting Loop 24 Fr Electrode-Sterile, Single-Use BIP30CLM Bipolar 30° Medium Cutting Loop 24 Fr Electrode-Sterile, Single-Use BIP30CLL Bipolar 30° Large Cutting Loop 24 Fr Electrode-Sterile, Single-Use BIPMBLA Bipolar Medium Bladder Loop 24 Fr Electrode-Sterile, Single-Use BIPNEEL Bipolar Needle 24 Fr Electrode-Sterile, Single-Use BIPDDSC Bipolar Disc ) | Dornier Medtech America Inc (Dmta) | Dec 5, 2025 | SESE |
| K250522 | Multi4 System | Multi4 Medical AB | Jun 27, 2025 | SESE |
| K240504 | PLASMA EDGE System | Lamidey Noury Medical | Jun 12, 2024 | SESE |
| K213135 | Plasma Edge resection and vaporization electrodes, Plasma Edge working elements, Adaptor Plasma Edge | Chirurgie Innovation | Mar 2, 2022 | SESE |
| K210651 | Resection Electrodes with HF cable | Olympus Winter & Ibe GmbH | Aug 3, 2021 | SESE |
| K210394 | Electrosurgical accessory | Dornier Medtech America, Inc. | May 19, 2021 | SESE |
| K171965 | Resection Electrodes with HF cable | Olympus Winter & Ibe GmbH | Sep 28, 2017 | SESE |
| K163090 | Plasma Edge System | Chirurgie Innovation | May 23, 2017 | SESE |
| K151976 | Omnitech HF Resection Electrodes, Omnitech HF Vaporization Electrode | Omnitech Systems, Inc. | Jun 27, 2016 | SESE |
| K152092 | Resection Electrodes | Olympus Winter & Ibe GmbH | Oct 26, 2015 | SESE |
| K120567 | GYRUS AMCI PK BUTTON ELECTRODE | Gyrus Acmi, Inc. | Jun 20, 2012 | SESE |
| K120418 | ELECTROSUGRICAL RESECTION AND VAPORIZATION ELECTRODE SERIES | Olympus Winter & Ibe GmbH | Jun 20, 2012 | SESE |
| K102781 | RESECTION BUTTON ELECTRODE FOR PLASMA VAPORIZATION, HF-RESECTION ELECTRODE ROLLERS AND NEEDLES, LOOPS AND BANDS | Olympus Winter & Ibe GmbH | Jan 11, 2011 | SESE |
| K100275 | WORKING ELEMENT, RESECTION BUTTON ELECTRODE FOR PLASMA VAPORIZATON, HF-RESECTION ELECTRODE LOOPS AND BANDS | Olympus Winter & Ibe GmbH | Jul 1, 2010 | SESE |
| K093181 | GYRUS ACMI PK BUTTON ELECTRODE | Gyrus Acmi, Inc. | Feb 24, 2010 | SESE |
| K091511 | MODERN MEDICAL RESECTOSCOPE ELECTRODES | Modern Medical Equipment Mfg., Ltd. | Jan 15, 2010 | SESE |
| K061541 | KSEA BIPOLAR ELECTROTOME | Ksea | Aug 21, 2006 | SESE |
| K053322 | MODIFICATION TO: ROEI WORKING ELEMENT AND ROEI CUTTING LOOPS | Roei Medical Technologies, Ltd. | Jan 6, 2006 | SESE |
| K050910 | ROEI WORKING ELEMENT AND ROEL CUTTING LOOPS | Roei Medical Technologies, Ltd. | Jun 16, 2005 | SESE |
| K050454 | OMNITECH FULGURATING ELECTRODE | Omnitech Systems, Inc. | May 27, 2005 | SESE |
Top Applicants
- Olympus Winter & Ibe GmbH — 6 clearances
- Arthrocare Corp. — 5 clearances
- Omnitech Systems, Inc. — 4 clearances
- Greenwald Surgical Co., Inc. — 3 clearances
- American Medical Systems, Inc. — 2 clearances
