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FJL — Resectoscope Class II

FDA Device Classification

Classification Details

Product Code
FJL
Device Class
Class II
Regulation Number
876.1500
Submission Type
Review Panel
GU
Medical Specialty
Gastroenterology, Urology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K232486karl storz se and co. kgKARL STORZ Monopolar Resectoscopes with HF CableMay 7, 2024
K221893karl storz endoscopy americaKARL STORZ Bipolar Resectoscopes with HF CableMarch 17, 2023
K230205corinth medtechVeloxion SystemFebruary 24, 2023
K191341corinth medtechVeloxion Controller Kit, Veloxion Fluid Control Set, Veloxion Resectoscope, VeloJune 13, 2019
K190099corinth medtechVeloxion Controller Kit, Veloxion Fluid Control Kit, Veloxion Resectoscope, VeloMarch 15, 2019
K162979corinth medtechVeloxion SystemMarch 24, 2017
K102663national advanced endoscopy devicesAED RESECTOSCOPEDecember 30, 2010
K062720richard wolf medical instrumentsS-LINE BIPOLAR RESECTOSCOPES AND BIPOLAR ELECTRODESMarch 22, 2007
K042523richard wolf medical instrumentsRESECTION PUMP, RESECTOSCOPE FOR CHIP ASPIRATION, ENDOSCOPE 25/ 3.3 MM, ACCESSORMarch 18, 2005
K041610richard wolf medical instrumentsMORCE SCOPE SET 8970 WITH POWER CONTROL 2303 AND SUCTION PUMP 2207August 19, 2004
K001270gyrus medicalGYRUS ENDOUROLOGY SYSTEM: AXIPOLAR RESECTOSCOPE LOOP ELECTRODEApril 28, 2000
K971881comeg endoscopyCOMEG RESECTOSCOPE AND LASER-RESECTOSCOPE WORKING ELEMENTS/URETHROTOMES/ELECTRODAugust 12, 1997
K964892gynecare innovation centerFEMRX TURP SR SYSTEM (TS27XX-YY/TS24XX-YY)February 4, 1997
K962506gynecare innovation center[SPECIALIZED TISSUE ASPIRATING RESECTOSCOPE (STAR)]September 16, 1996
K960757karl storz endoscopy-americaKARL STORZ URETER RESECTOSCOPEMay 1, 1996
K954050karl storz endoscopy-americaRESECTOSCOPESNovember 22, 1995
K952574karl storz endoscopy-americaKARL STORZ INSULATED GROOVED, SKIKED, ABLATOR, FIXED BARREL WITH GROOVES, COAGULJuly 20, 1995
K934835olympusFLOVALJune 21, 1994
K936038surgical laser technologiesSLT LASER CONTINUOUS FLOW TESECTOSCOPE (CFR)May 27, 1994
K934647karl storz endoscopy-americaKARL STORZ CUTTING LOOP ELECTRODES MODIFICATIONFebruary 9, 1994