Atlas FDA

FAS

58 FDA 510(k) clearances · Product code

119 daysmedian time to decision
276 days90th percentile
58clearances measured

FDA profile

Official device name
Electrode, Electrosurgical, Active, Urological
Device class
Class II (moderate risk)
Regulation
21 CFR 876.4300
Medical specialty
Gastroenterology, Urology
Flags
Third-party review eligible
Adverse events (MAUDE)
2021: 102 · 2022: 147 · 2023: 329 · 2024: 310 · 2025: 403 · 2026: 234
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Sort:Newest firstOldest first

Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
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 ) (K251403)Dornier Medtech America Inc (Dmta)2025-12-05
Multi4 System (K250522)Multi4 Medical AB2025-06-27
PLASMA EDGE System (K240504)Lamidey Noury Medical2024-06-12
Plasma Edge resection and vaporization electrodes, Plasma Edge working elements, Adaptor Plasma Edge (K213135)Chirurgie Innovation2022-03-02
Resection Electrodes with HF cable (K210651)Olympus Winter & Ibe GmbH2021-08-03
Electrosurgical accessory (K210394)Dornier Medtech America, Inc.2021-05-19
Resection Electrodes with HF cable (K171965)Olympus Winter & Ibe GmbH2017-09-28
Plasma Edge System (K163090)Chirurgie Innovation2017-05-23
Omnitech HF Resection Electrodes, Omnitech HF Vaporization Electrode (K151976)Omnitech Systems, Inc.2016-06-27
Resection Electrodes (K152092)Olympus Winter & Ibe GmbH2015-10-26
GYRUS AMCI PK BUTTON ELECTRODE (K120567)Gyrus Acmi, Inc.2012-06-20
ELECTROSUGRICAL RESECTION AND VAPORIZATION ELECTRODE SERIES (K120418)Olympus Winter & Ibe GmbH2012-06-20
RESECTION BUTTON ELECTRODE FOR PLASMA VAPORIZATION, HF-RESECTION ELECTRODE ROLLERS AND NEEDLES, LOOPS AND BANDS (K102781)Olympus Winter & Ibe GmbH2011-01-11
WORKING ELEMENT, RESECTION BUTTON ELECTRODE FOR PLASMA VAPORIZATON, HF-RESECTION ELECTRODE LOOPS AND BANDS (K100275)Olympus Winter & Ibe GmbH2010-07-01
GYRUS ACMI PK BUTTON ELECTRODE (K093181)Gyrus Acmi, Inc.2010-02-24
MODERN MEDICAL RESECTOSCOPE ELECTRODES (K091511)Modern Medical Equipment Mfg., Ltd.2010-01-15
KSEA BIPOLAR ELECTROTOME (K061541)Ksea2006-08-21
MODIFICATION TO: ROEI WORKING ELEMENT AND ROEI CUTTING LOOPS (K053322)Roei Medical Technologies, Ltd.2006-01-06
ROEI WORKING ELEMENT AND ROEL CUTTING LOOPS (K050910)Roei Medical Technologies, Ltd.2005-06-16
OMNITECH FULGURATING ELECTRODE (K050454)Omnitech Systems, Inc.2005-05-27
TURBT-RF ELECTRODES AND ELECTROSURGICAL DEVICES (K050488)Prosurg, Inc.2005-04-01
ARTHROCARE BIPOLAR ELECTROSURGERY SYSTEM (K031029)Arthrocare Corp.2003-06-19
ACMI VISTA CTR BIPOLAR LOOP ELECTRODE (K031001)Acmi Corporation2003-05-21
ARTHROCARE BIPOLAR ELECTROSURGERY SYSTEM (K022543)Arthrocare Corp.2002-08-30
COAGULOOP (K991314)American Medical Systems, Inc.1999-06-29
USA ELITE SYSTEM VAPORTRODE VAPORIZATION ELECTRODE AND VAPORTOME RESECTION ELECTRODE (K973820)Circon Corp.1998-05-12
ISOLATED SALINE ELECTRODES/PROBES/DEVICES-SALINETRODE (K981256)Ximed/Prosure/Injectx1998-05-12
ELECTRODES/PROBES/DEVICES (K974637)Ximed/Prosure/Injectx1998-01-07
ENDOLAP RESECTOSCOPE CUTTING LOOP ELECTRODE (K974516)Endolap, Inc.1997-12-22
ENDOLAP RESECTOSCOPE ROLLER ELECTRODE (K974515)Endolap, Inc.1997-12-22
AMS COAGULOOP RESECTION ELECTRODE (K971512)American Medical Systems, Inc.1997-07-24
ARTHROCARE MONOPOLAR ELECTROSURGERY LOOP (K970526)Arthrocare Corp.1997-05-28
VAPOR-TECH SLED ELECTRODE (K970717)Northgate Technologies, Inc.1997-05-08
RESECTOSCOPE CUTTING LOOP ELECTRODE (K964365)Omnitech Systems, Inc.1997-04-22
OMNITECH RESECTOSCOPE ROLLER ELECTRODE (K965093)Omnitech Systems, Inc.1997-03-19
ENDOCARE MONOPOLAR ELECTRODE (K965118)Endocare, Inc.1997-02-25
MICROGYN RESECTION LOOP, COAGULATING ELECTRODE, CISS SHEATH ELECTRODE, LOOP ELECTRODE KIT AND COAGULATING ELECTRODE KIT (K962653)Microgyn Corp.1997-02-04
BARD COAGULATING RESECTOR MODEL (3552XX; XX=01,02,03,04,05 OR 06) (K962538)C.R. Bard, Inc.1996-12-17
BARD V-MAX ROLLER BAR (3551XX;XX=01,02,03,04,05, OR 06) (K961841)C.R. Bard, Inc.1996-10-09
EVAP-ELECTRODES TYPES 8423, 8427, 8410 & 8413 ELECTROSURGICAL VAPORIZATION OF SOFT TISSUE (K953983)Richard Wolf Medical Instruments Corp.1996-10-02
KSEA VAPORIZATION ELECTRODES (K961702)Karl Storz Endoskop GmbH1996-08-29
ARTHROCARE UROLOGIC MULTI-ELECTRODE ELECTROSURGERY SYSTEM (K961069)Arthrocare Corp.1996-05-28
VAPOR-TECH ROLLER BALL ELECTRODE 24 FR. (K954710)Northgate Technologies, Inc.1996-04-24
ARTHROCARE BIPOLAR LOOP ELECTRODE SYSTEM (K955531)Arthrocare Corp.1996-02-21
SYMBIOSIS MONOPOLAR ELECTROSURGICAL ROLLER ELECTRODES (K953453)Symbiosis Corp.1996-01-17
ROLLER ELECTRODE (K951863)Olympus America, Inc.1995-08-24
POWER RESECTOSCOPE CUTTING LOOP (K951897)Power Analytics Corp.1995-07-18
ENDOSCOPIC ACCESSORY (K945191)Un-I-Med, Inc.1995-05-03
RESECTOSCOPE ELECTRO CAUTERY CUTTING LOOP (K943879)American Urologicals, Inc.1995-02-07
KARL STORZ UNIPOLAR BALL, NEEDLE, LOOP ELECTRODES (K944795)KARL STORZ Endoscopy-America, Inc.1994-12-21
HF-RESECTION ELECTRODE, LOOP W/RUNNER ENDOS/ACCESS (K931763)Olympus Corp.1994-08-29
GREENWALD CONTROL-TIP CYSTOSCOPIC ELECTRODE (K933173)Greenwald Surgical Co., Inc.1994-04-01
GREENWALD CONTROL TIP URETEROSCOPIC ELECTRODE (K933175)Greenwald Surgical Co., Inc.1994-04-01
GREENWALD FLEXIBLE ENDOSCOPIC ELECTRODE (K933174)Greenwald Surgical Co., Inc.1994-04-01
URETHRAL ELECTRODE SHEATH (K915219)Applied Urology, Inc.1992-07-23
FLEXIBLE ENDOSCOPIC ELECTRODE (K905731)Applied Urology, Inc.1991-01-31
CONTROL-TIP CYSTOSCOPIC ELECTRODES (K903156)North American Sterilization & Packaging Co.1990-12-18
FLEXIBLE ENDOSCOPIC ELECTRODES (K903162)North American Sterilization & Packaging Co.1990-12-18

Track FAS automatically

Every clearance here is in the API, with alerts when new ones post.