Product code FAS
- Device name
- Electrode, Electrosurgical, Active, Urological
- Medical specialty
- Gastroenterology, Urology
- Device class
- 2
- Regulation number
- 876.4300
- Review panel
- GU
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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-... | Dornier Medtech America Inc (Dmta) | 2025-12-05 |
| K250522 | Multi4 System | Multi4 Medical AB | 2025-06-27 |
| K240504 | PLASMA EDGE System | Lamidey Noury Medical | 2024-06-12 |
| K213135 | Plasma Edge resection and vaporization electrodes, Plasma Edge working elements, Adaptor Plasma Edge | Chirurgie Innovation | 2022-03-02 |
| K210651 | Resection Electrodes with HF cable | Olympus Winter & Ibe GmbH | 2021-08-03 |
| K210394 | Electrosurgical accessory | Dornier Medtech America, Inc. | 2021-05-19 |
| K171965 | Resection Electrodes with HF cable | Olympus Winter & Ibe GmbH | 2017-09-28 |
| K163090 | Plasma Edge System | Chirurgie Innovation | 2017-05-23 |
| K151976 | Omnitech HF Resection Electrodes, Omnitech HF Vaporization Electrode | Omnitech Systems, Inc. | 2016-06-27 |
| K152092 | Resection Electrodes | Olympus Winter & Ibe GmbH | 2015-10-26 |
| K120418 | ELECTROSUGRICAL RESECTION AND VAPORIZATION ELECTRODE SERIES | Olympus Winter & Ibe GmbH | 2012-06-20 |
| K120567 | GYRUS AMCI PK BUTTON ELECTRODE | Gyrus Acmi, Inc. | 2012-06-20 |
| K102781 | RESECTION BUTTON ELECTRODE FOR PLASMA VAPORIZATION, HF-RESECTION ELECTRODE ROLLERS AND NEEDLES, LOOPS AND BANDS | Olympus Winter & Ibe GmbH | 2011-01-11 |
| K100275 | WORKING ELEMENT, RESECTION BUTTON ELECTRODE FOR PLASMA VAPORIZATON, HF-RESECTION ELECTRODE LOOPS AND BANDS | Olympus Winter & Ibe GmbH | 2010-07-01 |
| K093181 | GYRUS ACMI PK BUTTON ELECTRODE | Gyrus Acmi, Inc. | 2010-02-24 |
| K091511 | MODERN MEDICAL RESECTOSCOPE ELECTRODES | Modern Medical Equipment Mfg., Ltd. | 2010-01-15 |
| K061541 | KSEA BIPOLAR ELECTROTOME | Ksea | 2006-08-21 |
| K053322 | MODIFICATION TO: ROEI WORKING ELEMENT AND ROEI CUTTING LOOPS | Roei Medical Technologies, Ltd. | 2006-01-06 |
| K050910 | ROEI WORKING ELEMENT AND ROEL CUTTING LOOPS | Roei Medical Technologies, Ltd. | 2005-06-16 |
| K050454 | OMNITECH FULGURATING ELECTRODE | Omnitech Systems, Inc. | 2005-05-27 |
| K050488 | TURBT-RF ELECTRODES AND ELECTROSURGICAL DEVICES | Prosurg, Inc. | 2005-04-01 |
| K031029 | ARTHROCARE BIPOLAR ELECTROSURGERY SYSTEM | Arthrocare Corp. | 2003-06-19 |
| K031001 | ACMI VISTA CTR BIPOLAR LOOP ELECTRODE | Acmi Corporation | 2003-05-21 |
| K022543 | ARTHROCARE BIPOLAR ELECTROSURGERY SYSTEM | Arthrocare Corp. | 2002-08-30 |
| K991314 | COAGULOOP | American Medical Systems, Inc. | 1999-06-29 |
| K981256 | ISOLATED SALINE ELECTRODES/PROBES/DEVICES-SALINETRODE | Ximed/Prosure/Injectx | 1998-05-12 |
| K973820 | USA ELITE SYSTEM VAPORTRODE VAPORIZATION ELECTRODE AND VAPORTOME RESECTION ELECTRODE | Circon Corp. | 1998-05-12 |
| K974637 | ELECTRODES/PROBES/DEVICES | Ximed/Prosure/Injectx | 1998-01-07 |
| K974516 | ENDOLAP RESECTOSCOPE CUTTING LOOP ELECTRODE | Endolap, Inc. | 1997-12-22 |
| K974515 | ENDOLAP RESECTOSCOPE ROLLER ELECTRODE | Endolap, Inc. | 1997-12-22 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 07613327055399 | NA | STRYKER CORPORATION | 2016-09-23 |
| 07613327059892 | NA | STRYKER CORPORATION | 2016-09-23 |
| 07613327059885 | NA | STRYKER CORPORATION | 2016-09-23 |
| 07613327059854 | NA | STRYKER CORPORATION | 2016-09-23 |
| 07613327059793 | NA | STRYKER CORPORATION | 2016-09-23 |
| 07613327059595 | NA | STRYKER CORPORATION | 2016-09-23 |
| 07613327059540 | NA | STRYKER CORPORATION | 2016-09-23 |
| 07613327059533 | NA | STRYKER CORPORATION | 2016-09-23 |
| 07613327059502 | NA | STRYKER CORPORATION | 2016-09-23 |
| 07613327059472 | NA | STRYKER CORPORATION | 2016-09-23 |
| 07613327055597 | Rev360 | STRYKER CORPORATION | 2016-09-23 |
| 07613327055573 | Rev360 | STRYKER CORPORATION | 2016-09-23 |
| 07613327055542 | Rev360 | STRYKER CORPORATION | 2016-09-23 |
| 07613327055498 | NA | STRYKER CORPORATION | 2016-09-23 |
| 07613327055405 | NA | STRYKER CORPORATION | 2016-09-23 |
| 07613327053777 | NA | STRYKER CORPORATION | 2016-09-23 |
| 07613327055313 | NA | STRYKER CORPORATION | 2016-09-23 |
| 07613327054071 | NA | STRYKER CORPORATION | 2016-09-23 |
| 07613327054064 | NA | STRYKER CORPORATION | 2016-09-23 |
| 07613327054057 | NA | STRYKER CORPORATION | 2016-09-23 |
| 07613327054040 | NA | STRYKER CORPORATION | 2016-09-23 |
| 07613327054033 | NA | STRYKER CORPORATION | 2016-09-23 |
| 07613327054026 | NA | STRYKER CORPORATION | 2016-09-23 |
| 07613327054019 | NA | STRYKER CORPORATION | 2016-09-23 |
| 07613327053869 | NA | STRYKER CORPORATION | 2016-09-23 |
| 07613327053852 | NA | STRYKER CORPORATION | 2016-09-23 |
| 07613327053814 | NA | STRYKER CORPORATION | 2016-09-23 |
| 07613327053807 | NA | STRYKER CORPORATION | 2016-09-23 |
| 07613327053791 | NA | STRYKER CORPORATION | 2016-09-23 |
| 07613327053784 | NA | STRYKER CORPORATION | 2016-09-23 |