Electrode, Electrosurgical, Active, Urological
FDA product code FAS · Class II (moderate risk) · 21 CFR 876.4300 · Gastroenterology, Urology
58510(k) clearances
0PMA approvals
9recalls
Manufacturers
- Olympus Winter & Ibe GmbH 6
- Arthrocare Corp. 5
- Omnitech Systems, Inc. 4
- Greenwald Surgical Co., Inc. 3
- Ximed/Prosure/Injectx 2
- North American Sterilization & Packaging Co. 2
- Endolap, Inc. 2
- American Medical Systems, Inc. 2
- Roei Medical Technologies, Ltd. 2
- Gyrus Acmi, Inc. 2
- C.R. Bard, Inc. 2
- Northgate Technologies, Inc. 2
- Chirurgie Innovation 2
- Applied Urology, Inc. 2
- Karl Storz Endoskop GmbH 1
- Symbiosis Corp. 1
- Power Analytics Corp. 1
- Dornier Medtech America Inc (Dmta) 1
- American Urologicals, Inc. 1
- KARL STORZ Endoscopy-America, Inc. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K251403 | Dornier Bi-Polar Electrode BIP12CLM Bipolar 12° Medium Cutting Loop 24 Fr…FAS · Traditional | Dornier Medtech America Inc (Dmta) | 12/05/2025SE |
| 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 |
| K120567 | Gyrus Amci PK Button ElectrodeFAS · Traditional | Gyrus Acmi, Inc. | 06/20/2012SE |
| K120418 | Electrosugrical Resection and Vaporization Electrode SeriesFAS · Special | Olympus Winter & Ibe GmbH | 06/20/2012SE |
| K102781 | Resection Button Electrode for Plasma Vaporization, Hf-Resection Electrode Rollers and…FAS · Special | Olympus Winter & Ibe GmbH | 01/11/2011SE |
| K100275 | Working Element, Resection Button Electrode for Plasma Vaporizaton, Hf-Resection…FAS · Traditional | Olympus Winter & Ibe GmbH | 07/01/2010SE |
| K093181 | Gyrus Acmi PK Button ElectrodeFAS · Traditional | Gyrus Acmi, Inc. | 02/24/2010SE |
| K091511 | Modern Medical Resectoscope ElectrodesFAS · Traditional | Modern Medical Equipment Mfg., Ltd. | 01/15/2010SE |
| K061541 | Ksea Bipolar ElectrotomeFAS · Traditional | Ksea | 08/21/2006SE |
| K053322 | Modification to: Roei Working Element and Roei Cutting LoopsFAS · Special | Roei Medical Technologies, Ltd. | 01/06/2006SE |
| K050910 | Roei Working Element and Roel Cutting LoopsFAS · Traditional | Roei Medical Technologies, Ltd. | 06/16/2005SE |
| K050454 | Omnitech Fulgurating ElectrodeFAS · Traditional | Omnitech Systems, Inc. | 05/27/2005SE |
| K050488 | Turbt-Rf Electrodes and Electrosurgical DevicesFAS · Traditional | Prosurg, Inc. | 04/01/2005SE |
| K031029 | Arthrocare Bipolar Electrosurgery SystemFAS · Traditional | Arthrocare Corp. | 06/19/2003SE |
| K031001 | Acmi Vista CTR Bipolar Loop ElectrodeFAS · Special | Acmi Corporation | 05/21/2003SE |
| K022543 | Arthrocare Bipolar Electrosurgery SystemFAS · Special | Arthrocare Corp. | 08/30/2002SE |
| K991314 | CoaguloopFAS · Traditional | American Medical Systems, Inc. | 06/29/1999SE |
| K981256 | Isolated Saline Electrodes/Probes/Devices-SalinetrodeFAS · Traditional | Ximed/Prosure/Injectx | 05/12/1998SE |
| K973820 | USA Elite System Vaportrode Vaporization Electrode and Vaportome Resection ElectrodeFAS · Traditional | Circon Corp. | 05/12/1998SE |
| K974637 | Electrodes/Probes/DevicesFAS · Traditional | Ximed/Prosure/Injectx | 01/07/1998SE |
| K974516 | Endolap Resectoscope Cutting Loop ElectrodeFAS · Traditional | Endolap, Inc. | 12/22/1997SE |
| K974515 | Endolap Resectoscope Roller ElectrodeFAS · Traditional | Endolap, Inc. | 12/22/1997SE |
| K971512 | Ams Coaguloop Resection ElectrodeFAS · Traditional | American Medical Systems, Inc. | 07/24/1997SE |
| K970526 | Arthrocare Monopolar Electrosurgery LoopFAS · Traditional | Arthrocare Corp. | 05/28/1997SE |
| K970717 | Vapor-Tech Sled ElectrodeFAS · Traditional | Northgate Technologies, Inc. | 05/08/1997SE |
| K964365 | Resectoscope Cutting Loop ElectrodeFAS · Traditional | Omnitech Systems, Inc. | 04/22/1997SE |
| K965093 | Omnitech Resectoscope Roller ElectrodeFAS · Traditional | Omnitech Systems, Inc. | 03/19/1997SE |
| K965118 | Endocare Monopolar ElectrodeFAS · Traditional | Endocare, Inc. | 02/25/1997SE |
| K962653 | Microgyn Resection Loop, Coagulating Electrode, Ciss Sheath Electrode, Loop Electrode…FAS · Traditional | Microgyn Corp. | 02/04/1997SE |
| K962538 | Bard Coagulating Resector Model (3552XX; XX=01,02,03,04,05 or 06)FAS · Traditional | C.R. Bard, Inc. | 12/17/1996SE |
| K961841 | Bard V-Max Roller Bar (3551XX;XX=01,02,03,04,05, or 06)FAS · Traditional | C.R. Bard, Inc. | 10/09/1996SE |
| K953983 | Evap-Electrodes Types 8423, 8427, 8410 & 8413 Electrosurgical Vaporization of Soft TissueFAS · Traditional | Richard Wolf Medical Instruments Corp. | 10/02/1996SE |
| K961702 | Ksea Vaporization ElectrodesFAS · Traditional | Karl Storz Endoskop GmbH | 08/29/1996SE |
| K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery SystemFAS · Traditional | Arthrocare Corp. | 05/28/1996SE |
| K954710 | Vapor-Tech Roller Ball Electrode 24 Fr.FAS · Traditional | Northgate Technologies, Inc. | 04/24/1996SE |
| K955531 | Arthrocare Bipolar Loop Electrode SystemFAS · Traditional | Arthrocare Corp. | 02/21/1996SE |
| K953453 | Symbiosis Monopolar Electrosurgical Roller ElectrodesFAS · Traditional | Symbiosis Corp. | 01/17/1996SE |
| K951863 | Roller ElectrodeFAS · Traditional | Olympus America, Inc. | 08/24/1995SE |
| K951897 | Power Resectoscope Cutting LoopFAS · Traditional | Power Analytics Corp. | 07/18/1995SE |
| K945191 | Endoscopic AccessoryFAS · Traditional | Un-I-Med, Inc. | 05/03/1995SE |
| K943879 | Resectoscope Electro Cautery Cutting LoopFAS · Traditional | American Urologicals, Inc. | 02/07/1995SE |
| K944795 | Karl Storz Unipolar Ball, Needle, Loop ElectrodesFAS · Traditional | KARL STORZ Endoscopy-America, Inc. | 12/21/1994SE |
| K931763 | Hf-Resection Electrode, Loop W/Runner Endos/AccessFAS · Traditional | Olympus Corp. | 08/29/1994SE |
| K933175 | Greenwald Control Tip Ureteroscopic ElectrodeFAS · Traditional | Greenwald Surgical Co., Inc. | 04/01/1994SE |
| K933174 | Greenwald Flexible Endoscopic ElectrodeFAS · Traditional | Greenwald Surgical Co., Inc. | 04/01/1994SE |
| K933173 | Greenwald Control-Tip Cystoscopic ElectrodeFAS · Traditional | Greenwald Surgical Co., Inc. | 04/01/1994SE |
| K915219 | Urethral Electrode SheathFAS · Traditional | Applied Urology, Inc. | 07/23/1992SE |
| K905731 | Flexible Endoscopic ElectrodeFAS · Traditional | Applied Urology, Inc. | 01/31/1991SE |
| K903162 | Flexible Endoscopic ElectrodesFAS · Traditional | North American Sterilization & Packaging Co. | 12/18/1990SE |
| K903156 | Control-Tip Cystoscopic ElectrodesFAS · Traditional | North American Sterilization & Packaging Co. | 12/18/1990SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0568-2024 Class II | ACMI Roller Bar Electrodes bearing incorrect pouch label of ACMI USA Elite System and…Incorrect pouch labels, the contents within the mislabeled pouch were Roller Bar electrodes. | Olympus Corporation of the Americas | 10/02/2023Open, Classified |
| Z-2413-2023 Class II | HF Resection Electrodes - HF resection electrodes are part of a resectoscope system for…Additional Caution statements in IFU: (1) Due to complaints where the loop wire at the distal end of the HF… | Olympus Corporation of the Americas | 06/08/2023Open, Classified |
| Z-0990-2021 Class II | SD-240U-25 ELECTROSURGICAL SNARE, model no. SD-240U-25 - Product Usage: Used with…Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat… | Aomori Olympus Co., Ltd. | 01/04/2021Terminated |
| Z-0989-2021 Class II | SD-240U-15 ELECTROSURGICAL SNARE, model no. SD-240U-15 - Product Usage: Used with…Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat… | Aomori Olympus Co., Ltd. | 01/04/2021Terminated |
| Z-0988-2021 Class II | SD-240U-10 ELECTROSURGICAL SNARE, model no. SD-240U-10 - Product Usage: Used with…Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat… | Aomori Olympus Co., Ltd. | 01/04/2021Terminated |
| Z-0987-2021 Class II | SD-230U-20 ELECTROSURGICAL SNARE, model no. SD-230U-20 - Product Usage: Used with…Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat… | Aomori Olympus Co., Ltd. | 01/04/2021Terminated |
| Z-1952-2018 Class II | Gyrus ACMI Reusable Active Cord for Bovie/ValleyLab Generators, Catalog No C650-129A…There is a potential for the cord to spark and cause a fire. | Gyrus Acmi, Incorporated | 04/17/2018Terminated |
| Z-0754-2017 Class II | HF Cable WA00014A, Endoscopic electrosurgical unit and accessoriesSoftware malfunction that results in incorrect generation or display of error codes. | Olympus Corporation of the Americas | 11/03/2016Terminated |
| Z-0585-2017 Class II | C-Max" Cutting Loop Electrodes, Storz One-Stem, 24 Fr, .014in., .35 mm, Sterile, Rx…Defect; The contact part could possibly separate from the electrode affecting to functionality of the device. | C.R. Bard, Inc. | 10/12/2016Terminated |