FDA 510(k) Applications for Medical Device Product Code "HBI"
(Illuminator, Fiberoptic, Surgical Field)

FDA 510(k) Number Applicant Device Name Decision Date
K883856 ADVANCED SURGICAL PRODUCTS, INC. FIBEROPTIC BLUNT INTEGRAL PICK LIGHTPIPE 09/29/1988
K883858 ADVANCED SURGICAL PRODUCTS, INC. FIBEROPTIC SHARP INTEGRAL PICK LIGHTPIPE 09/29/1988
K883857 ADVANCED SURGICAL PRODUCTS, INC. FIBEROPTIC WIRE PICK LIGHTPIPE 09/29/1988
K890398 ADVANCED SURGICAL PRODUCTS, INC. RYAN-STYLE DIRECTED INFUSION MANIPULATOR 02/17/1989
K810299 ASPEN LABORATORIES, INC. FIBER OPTIC ADAPTERS#60-0891 02/27/1981
K810300 ASPEN LABORATORIES, INC. FIBER OPTIC ADAPTERS#60-0893 02/27/1981
K901108 BURTON FIBERLUME 03/28/1990
K983277 CUDA PRODUCTS CO. LIGHTSOURCE OR ILLUMINATOR MODEL I-100 12/16/1998
K922837 ENDOMEDIX S1500 XENON LIGHT SOURCE 11/03/1992
K021931 GULF MEDICAL FIBEROPTICS ENDOSCOPIC FIBEROPTIC CABLE 09/06/2002
K991208 ISOLUX AMERICA ENDOSCOPIC FIBEROPTIC CABLE 06/23/1999
K052979 ISOLUX LLC 1125 XSB XENON FIBER-OPTIC LIGHT SOURCE 10/31/2005
K163185 ISOLUX LLC OptiLux LED Illuminator 11/21/2016
K141781 KATALYST SURGICAL, LLC KOGENT SPETZLER LIGHTED SUCTION TUBES 04/09/2015
K904609 MEDICAL DYNAMICS, INC. XENON LIGHT SOURCE 12/18/1990
K853948 MINNESOTA SCIENTIFIC, INC. MINNESOTA SCIENTIFIC, INC. OMNI-BEAM 10/16/1985
K922462 NEXTEC CORP. NEXTEC FIBEROPTIC CABLES 09/21/1992
K920167 NEXTEC CORP. NEXTEC FIBEROPTIC ILLUMINAT 150 WATT/HALO/3500 KEL 03/23/1992
K933593 PROGRESSIVE DYNAMICS, INC. LUMINOUS 150 FIBEROPTIC ILLUMINATOR 10/28/1993
K921866 PROGRESSIVE DYNAMICS, INC. LUMINOUS 250 FIBEROPTIC ILLUMINATOR 07/08/1992
K111342 SCHOTT NORTH AMERICA LIGHT GUIDE CABLE 11/25/2011
K896549 STORZ INSTRUMENT CO. STORZ FIBEROPTIC ENDO-ILLUMINATORS 02/15/1990
K854587 STORZ INSTRUMENT CO. STORZ MVS DISPOSABLE FIBEROPTIC LIGHTPIPE 02/04/1986
K904616 STORZ INSTRUMENT CO. STORZ ULTRA-SOURCE HIGH OUTPUT ILLUMINATOR 04/19/1991
K904681 VISTEK CORP. VLS 5300 300W XENON LIGHT SOURCE 12/18/1990
K883201 VITALMETRICS, INC. VITAL-VUE ILLUMINATION, SUCTION & IRRIGATION SYS 09/26/1988
K882956 VITALMETRICS, INC. VITAL-VUE ILLUMINATION, SUCTION AND IRRIGATION 08/03/1988


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