Electrode, Electrosurgical, Active, Urological

Product Code: FAS

Gastroenterology/Urology Microwave Medical Products

Applicable Standards: No Standard Applicable. General Radiological Health Requirements Apply. [1000-1005]

Code of Federal Regulations: 876.4300


Radiation TypeMicrowave EMF
Radition SafetyAbbreviated
Annual ReportsNo

Products Classified as FAS

1730Electrode, Electrosurgical, Active, UrologicalEndoscopic Electrosurgical Unit And Accessories.

Total Product Life Cycle (TPLC) Devices

1730Electrode, Electrosurgical, Active, UrologicalEndoscopic Electrosurgical Unit And Accessories.

Pre-market Notifications for FAS

K213135Plasma Edge Resection And Vaporization Electrodes, Plasma Edge Working Elements, Adaptor Plasma EdgeChirurgie Innovation
K210394Electrosurgical AccessoryDornier MedTech America Inc.
K171965Resection Electrodes With HF CableOlympus Winter & Ibe GmbH
K163090Plasma Edge SystemChirurgie Innovation
K152092Resection ElectrodesOlympus Winter & Ibe GmbH
K151976Omnitech HF Resection Electrodes, Omnitech HF Vaporization ElectrodeOMNITECH SYSTEMS, INC.
K120567GYRUS AMCI PK BUTTON ELECTRODEGYRUS ACMI, INC.
K120418ELECTROSUGRICAL RESECTION AND VAPORIZATION ELECTRODE SERIESOLYMPUS WINTER & IBE GMBH
K102781RESECTION BUTTON ELECTRODE FOR PLASMA VAPORIZATION, HF-RESECTION ELECTRODE ROLLERS AND NEEDLES, LOOPS AND BANDSOLYMPUS WINTER & IBE GMBH
K100275WORKING ELEMENT, RESECTION BUTTON ELECTRODE FOR PLASMA VAPORIZATON, HF-RESECTION ELECTRODE LOOPS AND BANDSOLYMPUS WINTER & IBE GMBH
K093181GYRUS ACMI PK BUTTON ELECTRODEGYRUS ACMI, INC.
K091511MODERN MEDICAL RESECTOSCOPE ELECTRODESMODERN MEDICAL EQUIPMENT MFG., LTD.
K061541KSEA BIPOLAR ELECTROTOMEKSEA
K053322MODIFICATION TO: ROEI WORKING ELEMENT AND ROEI CUTTING LOOPSROEI MEDICAL TECHNOLOGIES, LTD.
K050910ROEI WORKING ELEMENT AND ROEL CUTTING LOOPSROEI MEDICAL TECHNOLOGIES, LTD.

Global Unique Device Identification Database

10801741018692ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL
10801741018685ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL
10801741018678ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL
10801741018661ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL
10801741018654ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL
10801741018647ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL
10801741018630ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL
10801741018623ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL
10801741018616ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL
10801741018609ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL
10801741018593ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL
10801741018586ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL
10801741018579ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL
10801741018562ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL
10801741018555ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL

Maude Adverse Events

OLYMPUS PLASMA LOOP MEDIUM 12 "/16"OLYMPUS MEDICAL SYSTEMS CORP.2020-03-31
HF-RESECTION ELECTRODEOLYMPUS MEDICAL SYSTEMS CORPORATION2020-03-30
HF-RESECTION ELECTRODE, LOOP, 24 FROLYMPUS WINTER & IBE GMBH2020-03-26
HF-RESECTION ELECTRODE "PLASMALOOP", LOOP, MEDIUM, 24 FR., 12?/16?, ESG TURISOLYMPUS WINTER & IBE GMBH2020-03-26
HF-RESECTION ELECTRODE, LOOP, 24 FR., 0.2 WIRE, MEDIUM, 12?, STERILE, SINGLE USEOLYMPUS WINTER & IBE GMBH2020-03-23
HF-RESECTION?ELECTRODE,?LOOP,?24?FR.,?0.2?WIRE,?MEDIUM,?12,?STERILE,?SINGLE?USEOLYMPUS WINTER & IBE GMBH2020-03-05
HF-RESECTION ELECTRODE "PLASMA-OVALBUTTON", OVAL BUTTON, 24 FR., 12?-30?OLYMPUS WINTER & IBE GMBH2020-03-03
HF-RESECTION ELECTRODE, LOOP, 24 FR., 0.2 WIRE, MEDIUM, 12?, STERILE, SINGLE USEOLYMPUS WINTER & IBE GMBH2020-02-21
CUTTING LOOP, BIPOLAR, 24/26 FRKARL STORZ SE & CO. KG2020-02-07
HF-RESECTION ELECTRODE "PLASMA-OVALBUTTON"OLYMPUS WINTER & IBE GMBH2020-02-06
HF-RESECTION ELECTRODE, ROLLER, 24-28 FR., 12? AND 30?, STERILE, SINGLE USEOLYMPUS WINTER & IBE GMBH2020-02-04
HF-RESECTION ELECTRODE "PLASMALOOP", LOOP, MEDIUM, 24 FR., 12?/16?, ESG TURISOLYMPUS WINTER & IBE GMBH2020-02-01
HF-RESECTION ELECTRODE "PLASMALOOP", LOOP, MEDIUM, 24 FR., 12?/16?, ESG TURISOLYMPUS WINTER & IBE GMBH2020-02-01
HF-RESECTION ELECTRODE "PLASMALOOP", LOOP, MEDIUM, 24 FROLYMPUS WINTER & IBE GMBH2020-02-01
HF-RESECTION ELECTRODE "PLASMALOOP", LOOP, MEDIUM, 24 FR.OLYMPUS WINTER & IBE GMBH2020-02-01
HF-RESECTION ELECTRODE, ROLLER, 24-28 FR., 12? AND 30?, STERILE, SINGLE USEOLYMPUS WINTER & IBE GMBH2020-01-31
HF-RESECTION ELECTRODE, LOOP, 24 FR., 0.2 WIRE, LARGE, 30?, STERILE, SINGLE USEOLYMPUS WINTER & IBE GMBH2020-01-27
CUTTING LOOP, BIPOLARKARL STORZ SE & CO. KG2020-01-22
CUTTING LOOP, BIPOLAR, 24/26 FRKARL STORZ SE & CO. KG2020-01-15
M3-GOLD AUTOCLAVABLE FOROBLIQUE TELESCOPE 30 DEGGYRUS ACMI, INC2020-01-09
HF-RESECTION ELECTRODE, LOOP, 24 FR., 0.2 WIRE, MEDIUM, 12?, STERILE, SINGLE USEOLYMPUS WINTER & IBE GMBH2019-12-16
GREENWALD SURGICAL CO BALL TIP FLEXIBLE ELECTRODEGREENWALD SURGICAL CO., INC.2019-11-25
HF-RESECTION ELECTRODE "PLASMALOOP", LOOPOLYMPUS WINTER & IBE GMBH2019-11-15
HF-RESECTION ELECTRODE "PLASMALOOP", LARGEOLYMPUS WINTER & IBE GMBH2019-11-13
HF-RESECTION ELECTRODE, LOOP, 24 FR., 0.2 WIRE, LARGE, 12?, STERILE, SINGLE USEOLYMPUS WINTER & IBE GMBH2019-11-04
PLASMA LOOPOLYMPUS CORPORATION2019-10-31
HF-RESECTION ELECTRODE, ROLLER, 24-28 FR., 12? AND 30?, STERILE, SINGLE USEOLYMPUS WINTER & IBE GMBH2019-10-25
HF-RESECTION ELECTRODE, ROLLER, 24-28 FR., 12? AND 30?, STERILE, SINGLE USEOLYMPUS WINTER & IBE GMBH2019-10-11
HF-RESECTION ELECTRODE, LOOP, 24 FR., 0.2 WIRE, MEDIUM, 12?, STERILE, SINGLE USEOLYMPUS WINTER & IBE GMBH2019-10-07
HF-RESECTION ELECTRODE, 45? NEEDLE, 24-28 FR., 12? AND 30?, FOR TURISOLYMPUS WINTER & IBE GMBH2019-10-04
HF-RESECTION ELECTRODE, LOOP, 24 FR., 0.2 WIRE, MEDIUM, 12?, STERILE, SINGLE USEOLYMPUS WINTER & IBE GMBH2019-10-02
BIPOLAR WORKING ELEMENT ONLY W/ SPRINGKARL STORZ SE & CO. KG2019-09-26
ROTATING CF RESECTOSCOPE INNER SHEATHGYRUS ACMI, INC2019-09-23
SALINETRODE FLEXPROSURG INC2019-09-20
CUTTING ELECTRODERICHARD WOLF MEDICAL INSTRUMENTS CORP.2019-09-19
HF-RESECTION ELECTRODE, LOOP, 24 FR., 0.2 WIRE, MEDIUM, 30?, STERILE, SINGLE USEOLYMPUS WINTER & IBE GMBH2019-09-12
HF-RESECTION ELECTRODE "PLASMALOOP", LOOP, MEDIUM, 24 FR., 12?-30?, PK TURISOLYMPUS WINTER & IBE GMBH2019-09-09
HF-RESECTION ELECTRODE "PLASMALOOP"OLYMPUS WINTER & IBE GMBH2019-08-22
HF-RESECTION ELECTRODE, LOOP, 24 FR., 0.2 WIRE, LARGE, 12?, STERILE, SINGLE USEOLYMPUS WINTER & IBE GMBH2019-08-16
HF-RESECTION ELECTRODE, LOOP, 24 FR., 0.2 WIRE, MEDIUM, 12?, STERILE, SINGLE USEOLYMPUS WINTER & IBE GMBH2019-08-14
MONOPOLAR ACTIVE CORD, BOVIE/VALLEYLAB GENERATORSGYRUS ACMI, INC2019-08-05
HF-RESECTION ELECTRODE, LOOP, 24 FR., 0.2 WIRE, MEDIUM, 12?, STERILE, SINGLE USEOLYMPUS WINTER & IBE GMBH2019-08-05
HF-RESECTION ELECTRODE, LOOP, 24 FR., 0.2 WIRE, MEDIUM, 30?, STERILE, SINGLE USEOLYMPUS WINTER & IBE GMBH2019-08-05
HF-RESECTION ELECTRODE, LOOP, 24 FR., 0.2 WIRE, MEDIUM, 12?, STERILE, SINGLE USEOLYMPUS WINTER & IBE GMBH2019-07-26
HF CABLE, BIPOLAR, 4 M, FOR ESG-400 SALINE MODEOLYMPUS WINTER & IBE GMBH2019-07-22
HF CABLE, BIPOLAR, 4 M, FOR ESG-400 SALINE MODEOLYMPUS WINTER & IBE GMBH2019-07-17
OLYMPUS PLASMA BANDSURGICAL INNOVATION CENTER/ OLYMPUS CORPORATION OF AMERICA2019-07-05
OLYMPUS PLASMA BANDSURGICAL INNOVATION CANTER/ OLYMPUS CORPORATION OF AMERICA2019-07-05
BUGBEE ELECTRODE2019-06-28
MONOPOLAR ACTIVE CORD, BOVIE/VALLEYLAB GENERATORSGYRUS ACMI, INC2019-06-18
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