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FBO — Cystourethroscope Class II

FDA Device Classification

Classification Details

Product Code
FBO
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
K244001karl storz se and co. kgKARL STORZ Cysto-Urethro-Fiberscope (11272CU1); KARL STORZ Cysto-Urethro-FiberscMay 2, 2025
K243409karl storz se and co. kgKARL STORZ Pediatric Cysto-Urethro-Fiberscope (11274BCU1)November 27, 2024
K131364karl storz endoscopy-americaFLEXIBLE CMOS-VIDEO-CYSTO-URETHROSCOPEJanuary 2, 2014
K082046karl storz endoscopy-americaKARL STORZ PEDIATRIC FLEXIBLE CYSTO-URETHRO-FIBERSCOPE, MODEL 11278C1/ACUI AND COctober 10, 2008
K080780epitekANCHORAGE SCOPE, MODEL 000003July 30, 2008
K062918karl storz endoscopy-americaKARL STORZ FLEXIBLE VIDEO-URETHRO-CYSTOSCOPE SYSTEMJanuary 17, 2007
K061646laserscopeLASERSCOPE GUIDED DELIVERY DEVICE (GDD) CYSTOURETHROSCOPE & ACCESSORIESJune 27, 2006
K011496richard wolf medical instrumentsCYSTO-URETHROSCOPES E-LINE EXISTING OF: SHEATHS, OBTURATORS, INSERTS, ATTCHEMENTAugust 10, 2001
K972979smith and nephewSMITH & NEPHEW IMAGES CYSTOURETHROSCOPES AND ACCESSORIES, SMITH & NEPHEW SEMI0RIDecember 11, 1997
K962474olympus americaOLYMPUS FG SERIES OF RAT TOOTH GRASPING FORCEPS (UROLOGY)December 20, 1996
K941992surgical technologiesCYSTOSCOPENovember 30, 1995
K951972cabot medicalCABOT MEDICAL ULTRA FLOW CYSTOURETHROSCOPE SYSTEM WITH OPERATING & DIAGNOSTIC SHJuly 21, 1995
K945185karl storz endoscopy-americaCYSTOSCOPE (78FAJ)ENDOSCOPE,FIBEROPTIC (78GDB)May 3, 1995
K934649galileo electro-opticsGALILEO ENDOSCOPESOctober 13, 1994
K943668karl storz endoscopy-americaKSEA CONTINOUS FLOW CYSTOSCOPESeptember 21, 1994
K935163richard wolf medical instrumentsCONTINUOUS IRRIGATION CYSTOURETHROSCOPESeptember 7, 1994
K904797surgitekSURGITEK GRADUATED CYSTOSCOPE (MODEL GC-16)March 5, 1991
K870679van-tecVAN-TEC MODULAR FLEXIBLE CYSTOURETHROSCOPEMarch 30, 1987
K843084olympusOLYMPUS CHP-P10 NEPHROSCOPE/CYSTOSCOPEJanuary 3, 1985