FDA 510(k) Applications for Medical Device Product Code "FJL"
(Resectoscope)

FDA 510(k) Number Applicant Device Name Decision Date
K971881 COMEG ENDOSCOPY COMEG RESECTOSCOPE AND LASER-RESECTOSCOPE WORKING ELEMENTS/URETHROTOMES/ELECTRODES/ALBARRAB DEFLECTORS 08/12/1997
K190099 Corinth MedTech, Inc. Veloxion Controller Kit, Veloxion Fluid Control Kit, Veloxion Resectoscope, Veloxion Video Control Unit, Veloxion Roll Stand, Waste Management Tubing, Tissue Catch 03/15/2019
K191341 Corinth MedTech, Inc. Veloxion Controller Kit, Veloxion Fluid Control Set, Veloxion Resectoscope, Veloxion Video Control Unit, Veloxion Roll Stand, Waste Management Tubing, Tissue Catch, Waste Management Bags 06/13/2019
K230205 Corinth MedTech, Inc. Veloxion System 02/24/2023
K162979 Corinth MedTech, Inc. Veloxion System 03/24/2017
K962506 GYNECARE INNOVATION CENTER [SPECIALIZED TISSUE ASPIRATING RESECTOSCOPE (STAR)] 09/16/1996
K964892 GYNECARE INNOVATION CENTER FEMRX TURP SR SYSTEM (TS27XX-YY/TS24XX-YY) 02/04/1997
K001270 GYRUS MEDICAL LTD. GYRUS ENDOUROLOGY SYSTEM: AXIPOLAR RESECTOSCOPE LOOP ELECTRODE 04/28/2000
K221893 KARL STORZ Endoscopy America, Inc KARL STORZ Bipolar Resectoscopes with HF Cable 03/17/2023
K960757 KARL STORZ ENDOSCOPY-AMERICA, INC. KARL STORZ URETER RESECTOSCOPE 05/01/1996
K102663 NATIONAL ADVANCED ENDOSCOPY DEVICES, INC. AED RESECTOSCOPE 12/30/2010
K041610 RICHARD WOLF MEDICAL INSTRUMENTS CORP. MORCE SCOPE SET 8970 WITH POWER CONTROL 2303 AND SUCTION PUMP 2207 08/19/2004
K042523 RICHARD WOLF MEDICAL INSTRUMENTS CORP. RESECTION PUMP, RESECTOSCOPE FOR CHIP ASPIRATION, ENDOSCOPE 25/ 3.3 MM, ACCESSORIES 03/18/2005
K062720 RICHARD WOLF MEDICAL INSTRUMENTS CORP. S-LINE BIPOLAR RESECTOSCOPES AND BIPOLAR ELECTRODES 03/22/2007


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