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FDA Product Code

FDA Product Code FGB — Clearance Directory

Device Class
Class II
21 CFR Citation
876.1500

510(k) Clearances — 119 records · page 2 of 2

K-Number Device Name Applicant Decision Date Clearance Type Summary
K926004 ENDOSCOPE AND ACCOSSORIES Endomedix 1993-02-10 Traditional PDF ↗
K923545 BARD 7 FR. FIBER OPTIC ASSEMBLY C.R. Bard, Inc. 1992-10-08 Traditional PDF ↗
K920750 BARD URETEROSCOPE DEFLECTION MODULE C.R. Bard, Inc. 1992-04-16 Traditional PDF ↗
K915458 URETEROSCOPE Psi Medical Products, Inc. 1992-01-30 Traditional PDF ↗
K914106 PENTAX URETERORENOFIBERSCOPE, MODEL FUR-10P Pentax Precision Instrument Corp. 1992-01-10 Traditional PDF ↗
K911411 BARD 3000 PLUS URETEROSCOPY SYSTEM C.R. Bard, Inc. 1991-04-25 Traditional PDF ↗
K904793 SURGITEK GRADUATED URETEROSCOPE (MODEL GU-8) Surgitek 1991-03-05 Traditional PDF ↗
K902773 SURGITEK(R) FLEXIBLE URETEROSCOPY INTRO/SHEATH SET Medical Engineering Corp. 1990-07-16 Traditional PDF ↗
K901214 RIGID URETEROSCOPE Applied Urology, Inc. 1990-06-01 Traditional PDF ↗
K900813 BARD SHORT RIGID URETEROSCOPE C.R. Bard, Inc. 1990-05-17 Traditional PDF ↗
K884153 CANDELA MINIFLEX DEFLECTABLE URETEROSCOPE Candela Laser Corp. 1988-12-28 Traditional PDF ↗
K883110 BARD URETEROSCOPIC DEVICE C.R. Bard, Inc. 1988-10-21 Traditional PDF ↗
K880802 SURGITEK ARTICULATING URETEROSCOPE MODEL SU-11 Medical Engineering Corp. 1988-05-26 Traditional PDF ↗
K880801 SURGITEK FLEXIBLE URETEROSCOPE SU-7 & SU-9 Medical Engineering Corp. 1988-05-26 Traditional PDF ↗
K872282 FLEXIBLE URETEROSCOPE Intramed Laboratories, Inc. 1987-09-14 Traditional PDF ↗
K862551 FUNS-10, FUNS-11 Reichert-Jung, Inc. 1986-09-12 Traditional PDF ↗
K852888 OLYMPUS RIGID URETERORENOSCOPE Olympus Corp. 1985-08-21 Traditional PDF ↗
K844143 OLYMPUS PF-27M FLEXIBLE URETERORENOSCOPE Olympus Corp. 1985-01-15 Traditional PDF ↗
K811535 MODEL FUS-1, FLEXIBLE URETEROSCOPE American Optical Corp. 1981-06-23 Traditional PDF ↗

Product code FGB · Class II · Gastroenterology, Urology. Data: openFDA.