BEUDAMED
    Product Code: FAS FDA class 2 21 CFR 876.4300

    Electrode, Electrosurgical, Active, Urological

    Gastroenterology, Urology

    The Active Urological Electrosurgical Electrode (product code FAS) is a specialized electrode that serves as the active element of a urological electrosurgical system, delivering electrical energy to tissue during procedures such as transurethral resection. It is an FDA Class 2 device (moderate risk), requiring 510(k) premarket clearance. It is regulated under 21 CFR 876.4300 in the Gastroenterology and Urology specialty. This device is eligible for third-party 510(k) review.

    View on FDA
    510(k)s
    57
    FEI Numbers
    67
    Registration Numbers
    67
    Unique Applicants
    34
    Years Active
    35

    Basic Information

    Product Code
    FAS
    Device Class
    FDA class 2
    Regulation Number
    876.4300
    Medical Specialty
    Gastroenterology, Urology
    Review Panel
    GU
    Submission Type
    1

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✓
    Third Party
    —
    Summary Malfunction Reporting

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 57 510(k) clearances via K numbers.

    K Number Device Name
    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
    K120567 GYRUS AMCI PK BUTTON ELECTRODE
    K120418 ELECTROSUGRICAL RESECTION AND VAPORIZATION ELECTRODE SERIES
    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
    K981256 ISOLATED SALINE ELECTRODES/PROBES/DEVICES-SALINETRODE
    K973820 USA ELITE SYSTEM VAPORTRODE VAPORIZATION ELECTRODE AND VAPORTOME RESECTION ELECTRODE
    K974637 ELECTRODES/PROBES/DEVICES
    K974516 ENDOLAP RESECTOSCOPE CUTTING LOOP ELECTRODE
    K974515 ENDOLAP RESECTOSCOPE ROLLER 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
    K933175 GREENWALD CONTROL TIP URETEROSCOPIC ELECTRODE
    K933174 GREENWALD FLEXIBLE ENDOSCOPIC ELECTRODE
    K933173 GREENWALD CONTROL-TIP CYSTOSCOPIC ELECTRODE
    K915219 URETHRAL ELECTRODE SHEATH
    K905731 FLEXIBLE ENDOSCOPIC ELECTRODE
    K903162 FLEXIBLE ENDOSCOPIC ELECTRODES
    K903156 CONTROL-TIP CYSTOSCOPIC ELECTRODES

    FEI Numbers

    This FDA classification entry is associated with 67 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 67 registration numbers. Click on an entry to view related FDA registrations.