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FGA — Kit, Nephroscope Class II

FDA Device Classification

Classification Details

Product Code
FGA
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
K232370karl storz se and co. kgPercutaneous Nephroscope SystemMay 1, 2024
K151308schoelly fiberopticSchoelly Nephroscope Set, Schoelly Ultra-Mini Nephroscope SetFebruary 9, 2016
K072594gyrus acmiGYRUS ACMI IPN-2505, INVISIO SMITH PERCUTANEOUS NEPHROSCOPE SYSTEMDecember 13, 2007
K994223richard wolf medical instrumentsNEPHROSCOPE, 12 DEGREES; DIAPHRAGM VALVE; IRRIGATION ATTACHMENT; NEPHROSCOPE, 20June 5, 2000
K950433karl storz endoscopy-americaKARL STORZ ENDOPYELOTOMY SET FOR ENDOSCOPIC UROLOGY PROCEDURESMarch 15, 1995
K940594karl storz endoscopy-americaKARL STORZ ADULT & PEDIATRIC NEPHROSCOPESeptember 9, 1994
K922826optimed technologiesFLEXIBLE FIBER OPTIC ENDOSCOPEFebruary 19, 1993
K853486olympusOLYMPUS RIGID PERCUTANEOUS NEPHROSCOPESeptember 12, 1985
K791182american cystocope makersACMI RIGI-FLEX NEPHORSCOPEJuly 30, 1979
K770729richard wolf medical instrumentsPYELOSCOPE SYSTEMApril 28, 1977