Product code FAS— Gastroenterology, Urology
ARTHROCARE BIPOLAR ELECTROSURGERY SYSTEM
- Classification name
- Electrode, Electrosurgical, Active, Urological
- Device class
- Class 2
- Regulation
- 21 CFR 876.4300
- Advisory panel
- Gastroenterology, Urology
- Total cleared
- 58
- First cleared
- Most recent
Market context for product code FAS
FDA has cleared devices under product code FAS between 1990 and 2025, filed by 34 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
last 15 years- 2025
- 2024
- 2022
- 2021
- 2017
- 2016
- 2015
- 2012
- 2011
- 2010
- 2006
- 2005
- 2003
- 2002
- 1999
Top applicants under product code FAS
Adverse events under product code FAS
product code FAS- Death
- 3
- Injury
- 344
- Malfunction
- 1,130
- Total
- 1,477
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recent clearances under product code FAS
- 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 )
- K250522 — Multi4 System
- K240504 — PLASMA EDGE System
- K213135 — Plasma Edge resection and vaporization electrodes, Plasma Edge working elements, Adaptor Plasma Edge
- K210651 — Resection Electrodes with HF cable
- K210394 — Electrosurgical accessory
- K171965 — Resection Electrodes with HF cable
- K163090 — Plasma Edge System
- K151976 — Omnitech HF Resection Electrodes, Omnitech HF Vaporization Electrode
- K152092 — Resection Electrodes
- K120418 — ELECTROSUGRICAL RESECTION AND VAPORIZATION ELECTRODE SERIES
- K120567 — GYRUS AMCI PK BUTTON ELECTRODE
- K102781 — RESECTION BUTTON ELECTRODE FOR PLASMA VAPORIZATION, HF-RESECTION ELECTRODE ROLLERS AND NEEDLES, LOOPS AND BANDS
- K100275 — WORKING ELEMENT, RESECTION BUTTON ELECTRODE FOR PLASMA VAPORIZATON, HF-RESECTION ELECTRODE LOOPS AND BANDS
- K093181 — GYRUS ACMI PK BUTTON ELECTRODE
- K091511 — MODERN MEDICAL RESECTOSCOPE ELECTRODES
- K061541 — KSEA BIPOLAR ELECTROTOME
- K053322 — MODIFICATION TO: ROEI WORKING ELEMENT AND ROEI CUTTING LOOPS
- K050910 — ROEI WORKING ELEMENT AND ROEL CUTTING LOOPS
- K050454 — OMNITECH FULGURATING ELECTRODE
- K050488 — TURBT-RF ELECTRODES AND ELECTROSURGICAL DEVICES
- K031029 — ARTHROCARE BIPOLAR ELECTROSURGERY SYSTEM
- K031001 — ACMI VISTA CTR BIPOLAR LOOP ELECTRODE
- K022543 — ARTHROCARE BIPOLAR ELECTROSURGERY SYSTEM
- K991314 — COAGULOOP
- K973820 — USA ELITE SYSTEM VAPORTRODE VAPORIZATION ELECTRODE AND VAPORTOME RESECTION ELECTRODE
- K981256 — ISOLATED SALINE ELECTRODES/PROBES/DEVICES-SALINETRODE
- K974637 — ELECTRODES/PROBES/DEVICES
- K974515 — ENDOLAP RESECTOSCOPE ROLLER ELECTRODE
- K974516 — ENDOLAP RESECTOSCOPE CUTTING LOOP ELECTRODE
- K971512 — AMS COAGULOOP RESECTION ELECTRODE
- K970526 — ARTHROCARE MONOPOLAR ELECTROSURGERY LOOP
- K970717 — VAPOR-TECH SLED ELECTRODE
- K964365 — RESECTOSCOPE CUTTING LOOP ELECTRODE
- K965093 — OMNITECH RESECTOSCOPE ROLLER ELECTRODE
- K965118 — ENDOCARE MONOPOLAR ELECTRODE
- K962653 — MICROGYN RESECTION LOOP, COAGULATING ELECTRODE, CISS SHEATH ELECTRODE, LOOP ELECTRODE KIT AND COAGULATING ELECTRODE KIT
- K962538 — BARD COAGULATING RESECTOR MODEL (3552XX; XX=01,02,03,04,05 OR 06)
- K961841 — BARD V-MAX ROLLER BAR (3551XX; XX=01,02,03,04,05, OR 06)
- K953983 — EVAP-ELECTRODES TYPES 8423, 8427, 8410 & 8413 ELECTROSURGICAL VAPORIZATION OF SOFT TISSUE
- K961702 — KSEA VAPORIZATION ELECTRODES
- K961069 — ARTHROCARE UROLOGIC MULTI-ELECTRODE ELECTROSURGERY SYSTEM
- K954710 — VAPOR-TECH ROLLER BALL ELECTRODE 24 FR.
- K955531 — ARTHROCARE BIPOLAR LOOP ELECTRODE SYSTEM
- K953453 — SYMBIOSIS MONOPOLAR ELECTROSURGICAL ROLLER ELECTRODES
- K951863 — ROLLER ELECTRODE
- K951897 — POWER RESECTOSCOPE CUTTING LOOP
- K945191 — ENDOSCOPIC ACCESSORY
- K943879 — RESECTOSCOPE ELECTRO CAUTERY CUTTING LOOP
- K944795 — KARL STORZ UNIPOLAR BALL, NEEDLE, LOOP ELECTRODES
- K931763 — HF-RESECTION ELECTRODE, LOOP W/RUNNER ENDOS/ACCESS
- K933173 — GREENWALD CONTROL-TIP CYSTOSCOPIC ELECTRODE
- K933174 — GREENWALD FLEXIBLE ENDOSCOPIC ELECTRODE
- K933175 — GREENWALD CONTROL TIP URETEROSCOPIC ELECTRODE
- K915219 — URETHRAL ELECTRODE SHEATH
- K905731 — FLEXIBLE ENDOSCOPIC ELECTRODE
- K903156 — CONTROL-TIP CYSTOSCOPIC ELECTRODES
- K903162 — FLEXIBLE ENDOSCOPIC ELECTRODES
Data sourced from openFDA. This site is unofficial and independent of the FDA.