FDA 510(k) Applications for Medical Device Product Code "FGA"
(Kit, Nephroscope)

FDA 510(k) Number Applicant Device Name Decision Date
K072594 GYRUS ACMI, INC. GYRUS ACMI IPN-2505, INVISIO SMITH PERCUTANEOUS NEPHROSCOPE SYSTEM 12/13/2007
K994223 RICHARD WOLF MEDICAL INSTRUMENTS CORP. NEPHROSCOPE, 12 DEGREES; DIAPHRAGM VALVE; IRRIGATION ATTACHMENT; NEPHROSCOPE, 20 DEGREE, STRAIGHT VIEW; NEPHROSCOPE, 20 06/05/2000
K151308 SCHOELLY FIBEROPTIC, GMBH Schoelly Nephroscope Set, Schoelly Ultra-Mini Nephroscope Set 02/09/2016


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