Panels › Gastroenterology, Urology › Product code FAS · Class 2
Electrode, Electrosurgical, Active, Urological
Regulation 876.4300
1510(k)s in 12 months (58 all time)
0recalls in 12 months (9 all time)
8recalls that name a 510(k)
Top companies in FAS
| Company | 510(k)s | Recalls |
|---|---|---|
| Olympus Winter & Ibe GmbH | 6 | 0 |
| Arthrocare Corp. | 5 | 0 |
| Aomori Olympus Co., Ltd. | 0 | 4 |
| Omnitech Systems, Inc. | 4 | 0 |
| C.R. Bard, Inc. | 2 | 1 |
| Greenwald Surgical Co., Inc. | 3 | 0 |
| Gyrus Acmi, Inc. | 2 | 1 |
| Olympus Corporation of the Americas | 0 | 3 |
| American Medical Systems, Inc. | 2 | 0 |
| Applied Urology, Inc. | 2 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 5, 2025 | K251403 | Dornier Bi-Polar Electrode BIP12CLM Bipolar 12° Medium Cutting Loop 24 Fr Electrode-Sterile, Single-Use BIP12CLL Bipola Dornier Medtech America Inc (Dmta) | FAS |
| Jun 27, 2025 | K250522 | Multi4 System Multi4 Medical AB, SE | FAS |
| Jun 12, 2024 | K240504 | PLASMA EDGE System Lamidey Noury Medical, FR | FAS |
| Mar 2, 2022 | K213135 | Plasma Edge resection and vaporization electrodes, Plasma Edge working elements, Adaptor Plasma Edge Chirurgie Innovation, FR | FAS |
| Aug 3, 2021 | K210651 | Resection Electrodes with HF cable Olympus Winter & Ibe GmbH, DE | FAS |
| May 19, 2021 | K210394 | Electrosurgical accessory Dornier Medtech America, Inc. | FAS |
| Sep 28, 2017 | K171965 | Resection Electrodes with HF cable Olympus Winter & Ibe GmbH, DE | FAS |
| May 23, 2017 | K163090 | Plasma Edge System Chirurgie Innovation, FR | FAS |
| Jun 27, 2016 | K151976 | Omnitech HF Resection Electrodes, Omnitech HF Vaporization Electrode Omnitech Systems, Inc. | FAS |
| Oct 26, 2015 | K152092 | Resection Electrodes Olympus Winter & Ibe GmbH, DE | FAS |
| Jun 20, 2012 | K120567 | GYRUS AMCI PK BUTTON ELECTRODE Gyrus Acmi, Inc. | FAS |
| Jun 20, 2012 | K120418 | ELECTROSUGRICAL RESECTION AND VAPORIZATION ELECTRODE SERIES Olympus Winter & Ibe GmbH | FAS |
| Jan 11, 2011 | K102781 | RESECTION BUTTON ELECTRODE FOR PLASMA VAPORIZATION, HF-RESECTION ELECTRODE ROLLERS AND NEEDLES, LOOPS AND BANDS Olympus Winter & Ibe GmbH | FAS |
| Jul 1, 2010 | K100275 | WORKING ELEMENT, RESECTION BUTTON ELECTRODE FOR PLASMA VAPORIZATON, HF-RESECTION ELECTRODE LOOPS AND BANDS Olympus Winter & Ibe GmbH | FAS |
| Feb 24, 2010 | K093181 | GYRUS ACMI PK BUTTON ELECTRODE Gyrus Acmi, Inc. | FAS |
| Jan 15, 2010 | K091511 | MODERN MEDICAL RESECTOSCOPE ELECTRODES Modern Medical Equipment Mfg., Ltd., CN | FAS |
| Aug 21, 2006 | K061541 | KSEA BIPOLAR ELECTROTOME Ksea | FAS |
| Jan 6, 2006 | K053322 | MODIFICATION TO: ROEI WORKING ELEMENT AND ROEI CUTTING LOOPS Roei Medical Technologies, Ltd. | FAS |
| Jun 16, 2005 | K050910 | ROEI WORKING ELEMENT AND ROEL CUTTING LOOPS Roei Medical Technologies, Ltd. | FAS |
| May 27, 2005 | K050454 | OMNITECH FULGURATING ELECTRODE Omnitech Systems, Inc. | FAS |
| Apr 1, 2005 | K050488 | TURBT-RF ELECTRODES AND ELECTROSURGICAL DEVICES Prosurg, Inc. | FAS |
| Jun 19, 2003 | K031029 | ARTHROCARE BIPOLAR ELECTROSURGERY SYSTEM Arthrocare Corp. | FAS |
| May 21, 2003 | K031001 | ACMI VISTA CTR BIPOLAR LOOP ELECTRODE Acmi Corporation | FAS |
| Aug 30, 2002 | K022543 | ARTHROCARE BIPOLAR ELECTROSURGERY SYSTEM Arthrocare Corp. | FAS |
| Jun 29, 1999 | K991314 | COAGULOOP American Medical Systems, Inc. | FAS |
| May 12, 1998 | K981256 | ISOLATED SALINE ELECTRODES/PROBES/DEVICES-SALINETRODE Ximed/Prosure/Injectx | FAS |
| May 12, 1998 | K973820 | USA ELITE SYSTEM VAPORTRODE VAPORIZATION ELECTRODE AND VAPORTOME RESECTION ELECTRODE Circon Corp. | FAS |
| Jan 7, 1998 | K974637 | ELECTRODES/PROBES/DEVICES Ximed/Prosure/Injectx | FAS |
| Dec 22, 1997 | K974516 | ENDOLAP RESECTOSCOPE CUTTING LOOP ELECTRODE Endolap, Inc. | FAS |
| Dec 22, 1997 | K974515 | ENDOLAP RESECTOSCOPE ROLLER ELECTRODE Endolap, Inc. | FAS |
| Jul 24, 1997 | K971512 | AMS COAGULOOP RESECTION ELECTRODE American Medical Systems, Inc. | FAS |
| May 28, 1997 | K970526 | ARTHROCARE MONOPOLAR ELECTROSURGERY LOOP Arthrocare Corp. | FAS |
| May 8, 1997 | K970717 | VAPOR-TECH SLED ELECTRODE Northgate Technologies, Inc. | FAS |
| Apr 22, 1997 | K964365 | RESECTOSCOPE CUTTING LOOP ELECTRODE Omnitech Systems, Inc. | FAS |
| Mar 19, 1997 | K965093 | OMNITECH RESECTOSCOPE ROLLER ELECTRODE Omnitech Systems, Inc. | FAS |
| Feb 25, 1997 | K965118 | ENDOCARE MONOPOLAR ELECTRODE Endocare, Inc. | FAS |
| Feb 4, 1997 | K962653 | MICROGYN RESECTION LOOP, COAGULATING ELECTRODE, CISS SHEATH ELECTRODE, LOOP ELECTRODE KIT AND COAGULATING ELECTRODE KIT Microgyn Corp. | FAS |
| Dec 17, 1996 | K962538 | BARD COAGULATING RESECTOR MODEL (3552XX; XX=01,02,03,04,05 OR 06) C.R. Bard, Inc. | FAS |
| Oct 9, 1996 | K961841 | BARD V-MAX ROLLER BAR (3551XX;XX=01,02,03,04,05, OR 06) C.R. Bard, Inc. | FAS |
| Oct 2, 1996 | K953983 | EVAP-ELECTRODES TYPES 8423, 8427, 8410 & 8413 ELECTROSURGICAL VAPORIZATION OF SOFT TISSUE Richard Wolf Medical Instruments Corp. | FAS |
| Aug 29, 1996 | K961702 | KSEA VAPORIZATION ELECTRODES Karl Storz Endoskop GmbH | FAS |
| May 28, 1996 | K961069 | ARTHROCARE UROLOGIC MULTI-ELECTRODE ELECTROSURGERY SYSTEM Arthrocare Corp. | FAS |
| Apr 24, 1996 | K954710 | VAPOR-TECH ROLLER BALL ELECTRODE 24 FR. Northgate Technologies, Inc. | FAS |
| Feb 21, 1996 | K955531 | ARTHROCARE BIPOLAR LOOP ELECTRODE SYSTEM Arthrocare Corp. | FAS |
| Jan 17, 1996 | K953453 | SYMBIOSIS MONOPOLAR ELECTROSURGICAL ROLLER ELECTRODES Symbiosis Corp. | FAS |
| Aug 24, 1995 | K951863 | ROLLER ELECTRODE Olympus America, Inc. | FAS |
| Jul 18, 1995 | K951897 | POWER RESECTOSCOPE CUTTING LOOP Power Analytics Corp. | FAS |
| May 3, 1995 | K945191 | ENDOSCOPIC ACCESSORY Un-I-Med, Inc. | FAS |
| Feb 7, 1995 | K943879 | RESECTOSCOPE ELECTRO CAUTERY CUTTING LOOP American Urologicals, Inc. | FAS |
| Dec 21, 1994 | K944795 | KARL STORZ UNIPOLAR BALL, NEEDLE, LOOP ELECTRODES KARL STORZ Endoscopy-America, Inc. | FAS |
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