FDA Product Code
FDA Product Code FAS — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Gastroenterology, Urology
- 21 CFR Citation
- 876.4300
510(k) Clearances — 58 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| 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) | 2025-12-05 | Traditional | PDF ↗ |
| K250522 | Multi4 System | Multi4 Medical AB | 2025-06-27 | Traditional | PDF ↗ |
| K240504 | PLASMA EDGE System | Lamidey Noury Medical | 2024-06-12 | Special | PDF ↗ |
| K213135 | Plasma Edge resection and vaporization electrodes, Plasma Edge working elements, Adaptor Plasma Edge | Chirurgie Innovation | 2022-03-02 | Special | PDF ↗ |
| K210651 | Resection Electrodes with HF cable | Olympus Winter & Ibe GmbH | 2021-08-03 | Traditional | PDF ↗ |
| K210394 | Electrosurgical accessory | Dornier Medtech America, Inc. | 2021-05-19 | Traditional | PDF ↗ |
| K171965 | Resection Electrodes with HF cable | Olympus Winter & Ibe GmbH | 2017-09-28 | Traditional | PDF ↗ |
| K163090 | Plasma Edge System | Chirurgie Innovation | 2017-05-23 | Traditional | PDF ↗ |
| K151976 | Omnitech HF Resection Electrodes, Omnitech HF Vaporization Electrode | Omnitech Systems, Inc. | 2016-06-27 | Traditional | PDF ↗ |
| K152092 | Resection Electrodes | Olympus Winter & Ibe GmbH | 2015-10-26 | Traditional | PDF ↗ |
| K120418 | ELECTROSUGRICAL RESECTION AND VAPORIZATION ELECTRODE SERIES | Olympus Winter & Ibe GmbH | 2012-06-20 | Special | PDF ↗ |
| K120567 | GYRUS AMCI PK BUTTON ELECTRODE | Gyrus Acmi, Inc. | 2012-06-20 | Traditional | PDF ↗ |
| K102781 | RESECTION BUTTON ELECTRODE FOR PLASMA VAPORIZATION, HF-RESECTION ELECTRODE ROLLERS AND NEEDLES, LOOPS AND BANDS | Olympus Winter & Ibe GmbH | 2011-01-11 | Special | PDF ↗ |
| K100275 | WORKING ELEMENT, RESECTION BUTTON ELECTRODE FOR PLASMA VAPORIZATON, HF-RESECTION ELECTRODE LOOPS AND BANDS | Olympus Winter & Ibe GmbH | 2010-07-01 | Traditional | PDF ↗ |
| K093181 | GYRUS ACMI PK BUTTON ELECTRODE | Gyrus Acmi, Inc. | 2010-02-24 | Traditional | PDF ↗ |
| K091511 | MODERN MEDICAL RESECTOSCOPE ELECTRODES | Modern Medical Equipment Mfg., Ltd. | 2010-01-15 | Traditional | PDF ↗ |
| K061541 | KSEA BIPOLAR ELECTROTOME | Ksea | 2006-08-21 | Traditional | PDF ↗ |
| K053322 | MODIFICATION TO: ROEI WORKING ELEMENT AND ROEI CUTTING LOOPS | Roei Medical Technologies, Ltd. | 2006-01-06 | Special | PDF ↗ |
| K050910 | ROEI WORKING ELEMENT AND ROEL CUTTING LOOPS | Roei Medical Technologies, Ltd. | 2005-06-16 | Traditional | PDF ↗ |
| K050454 | OMNITECH FULGURATING ELECTRODE | Omnitech Systems, Inc. | 2005-05-27 | Traditional | PDF ↗ |
| K050488 | TURBT-RF ELECTRODES AND ELECTROSURGICAL DEVICES | Prosurg, Inc. | 2005-04-01 | Traditional | PDF ↗ |
| K031029 | ARTHROCARE BIPOLAR ELECTROSURGERY SYSTEM | Arthrocare Corp. | 2003-06-19 | Traditional | PDF ↗ |
| K031001 | ACMI VISTA CTR BIPOLAR LOOP ELECTRODE | Acmi Corporation | 2003-05-21 | Special | PDF ↗ |
| K022543 | ARTHROCARE BIPOLAR ELECTROSURGERY SYSTEM | Arthrocare Corp. | 2002-08-30 | Special | PDF ↗ |
| K991314 | COAGULOOP | American Medical Systems, Inc. | 1999-06-29 | Traditional | PDF ↗ |
| K981256 | ISOLATED SALINE ELECTRODES/PROBES/DEVICES-SALINETRODE | Ximed/Prosure/Injectx | 1998-05-12 | Traditional | PDF ↗ |
| K973820 | USA ELITE SYSTEM VAPORTRODE VAPORIZATION ELECTRODE AND VAPORTOME RESECTION ELECTRODE | Circon Corp. | 1998-05-12 | Traditional | PDF ↗ |
| K974637 | ELECTRODES/PROBES/DEVICES | Ximed/Prosure/Injectx | 1998-01-07 | Traditional | PDF ↗ |
| K974516 | ENDOLAP RESECTOSCOPE CUTTING LOOP ELECTRODE | Endolap, Inc. | 1997-12-22 | Traditional | PDF ↗ |
| K974515 | ENDOLAP RESECTOSCOPE ROLLER ELECTRODE | Endolap, Inc. | 1997-12-22 | Traditional | PDF ↗ |
| K971512 | AMS COAGULOOP RESECTION ELECTRODE | American Medical Systems, Inc. | 1997-07-24 | Traditional | PDF ↗ |
| K970526 | ARTHROCARE MONOPOLAR ELECTROSURGERY LOOP | Arthrocare Corp. | 1997-05-28 | Traditional | PDF ↗ |
| K970717 | VAPOR-TECH SLED ELECTRODE | Northgate Technologies, Inc. | 1997-05-08 | Traditional | PDF ↗ |
| K964365 | RESECTOSCOPE CUTTING LOOP ELECTRODE | Omnitech Systems, Inc. | 1997-04-22 | Traditional | PDF ↗ |
| K965093 | OMNITECH RESECTOSCOPE ROLLER ELECTRODE | Omnitech Systems, Inc. | 1997-03-19 | Traditional | PDF ↗ |
| K965118 | ENDOCARE MONOPOLAR ELECTRODE | Endocare, Inc. | 1997-02-25 | Traditional | PDF ↗ |
| K962653 | MICROGYN RESECTION LOOP, COAGULATING ELECTRODE, CISS SHEATH ELECTRODE, LOOP ELECTRODE KIT AND COAGULATING ELECTRODE KIT | Microgyn Corp. | 1997-02-04 | Traditional | PDF ↗ |
| K962538 | BARD COAGULATING RESECTOR MODEL (3552XX; XX=01,02,03,04,05 OR 06) | C.R. Bard, Inc. | 1996-12-17 | Traditional | PDF ↗ |
| K961841 | BARD V-MAX ROLLER BAR (3551XX;XX=01,02,03,04,05, OR 06) | C.R. Bard, Inc. | 1996-10-09 | Traditional | PDF ↗ |
| K953983 | EVAP-ELECTRODES TYPES 8423, 8427, 8410 & 8413 ELECTROSURGICAL VAPORIZATION OF SOFT TISSUE | Richard Wolf Medical Instruments Corp. | 1996-10-02 | Traditional | PDF ↗ |
| K961702 | KSEA VAPORIZATION ELECTRODES | Karl Storz Endoskop GmbH | 1996-08-29 | Traditional | PDF ↗ |
| K961069 | ARTHROCARE UROLOGIC MULTI-ELECTRODE ELECTROSURGERY SYSTEM | Arthrocare Corp. | 1996-05-28 | Traditional | PDF ↗ |
| K954710 | VAPOR-TECH ROLLER BALL ELECTRODE 24 FR. | Northgate Technologies, Inc. | 1996-04-24 | Traditional | PDF ↗ |
| K955531 | ARTHROCARE BIPOLAR LOOP ELECTRODE SYSTEM | Arthrocare Corp. | 1996-02-21 | Traditional | PDF ↗ |
| K953453 | SYMBIOSIS MONOPOLAR ELECTROSURGICAL ROLLER ELECTRODES | Symbiosis Corp. | 1996-01-17 | Traditional | PDF ↗ |
| K951863 | ROLLER ELECTRODE | Olympus America, Inc. | 1995-08-24 | Traditional | PDF ↗ |
| K951897 | POWER RESECTOSCOPE CUTTING LOOP | Power Analytics Corp. | 1995-07-18 | Traditional | PDF ↗ |
| K945191 | ENDOSCOPIC ACCESSORY | Un-I-Med, Inc. | 1995-05-03 | Traditional | PDF ↗ |
| K943879 | RESECTOSCOPE ELECTRO CAUTERY CUTTING LOOP | American Urologicals, Inc. | 1995-02-07 | Traditional | PDF ↗ |
| K944795 | KARL STORZ UNIPOLAR BALL, NEEDLE, LOOP ELECTRODES | KARL STORZ Endoscopy-America, Inc. | 1994-12-21 | Traditional | PDF ↗ |
| K931763 | HF-RESECTION ELECTRODE, LOOP W/RUNNER ENDOS/ACCESS | Olympus Corp. | 1994-08-29 | Traditional | PDF ↗ |
| K933174 | GREENWALD FLEXIBLE ENDOSCOPIC ELECTRODE | Greenwald Surgical Co., Inc. | 1994-04-01 | Traditional | PDF ↗ |
| K933173 | GREENWALD CONTROL-TIP CYSTOSCOPIC ELECTRODE | Greenwald Surgical Co., Inc. | 1994-04-01 | Traditional | PDF ↗ |
| K933175 | GREENWALD CONTROL TIP URETEROSCOPIC ELECTRODE | Greenwald Surgical Co., Inc. | 1994-04-01 | Traditional | PDF ↗ |
| K915219 | URETHRAL ELECTRODE SHEATH | Applied Urology, Inc. | 1992-07-23 | Traditional | PDF ↗ |
| K905731 | FLEXIBLE ENDOSCOPIC ELECTRODE | Applied Urology, Inc. | 1991-01-31 | Traditional | PDF ↗ |
| K903156 | CONTROL-TIP CYSTOSCOPIC ELECTRODES | North American Sterilization & Packaging Co. | 1990-12-18 | Traditional | PDF ↗ |
| K903162 | FLEXIBLE ENDOSCOPIC ELECTRODES | North American Sterilization & Packaging Co. | 1990-12-18 | Traditional | PDF ↗ |
Product code FAS · Class II · Gastroenterology, Urology. Data: openFDA.