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HBI — Illuminator, Fiberoptic, Surgical Field Class II

FDA Device Classification

FDA product code HBI covers "Illuminator, Fiberoptic, Surgical Field", a Class II medical device regulated under 21 CFR 878.4580. Submissions are reviewed by the General, Plastic Surgery panel. At least 20 recent 510(k) clearances have been granted under this product code.

Classification Details

Product Code
HBI
Device Class
Class II
Regulation Number
878.4580
Submission Type
Review Panel
SU
Medical Specialty
General, Plastic Surgery
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K223183olympus winter and ibeLight-Guide CablesJanuary 13, 2023
K163185isoluxOptiLux LED IlluminatorNovember 21, 2016
K141781katalyst surgicalKOGENT SPETZLER LIGHTED SUCTION TUBESApril 9, 2015
K111342schott north americaLIGHT GUIDE CABLENovember 25, 2011
K052979isolux1125 XSB XENON FIBER-OPTIC LIGHT SOURCEOctober 31, 2005
K021931gulf medical fiberopticsENDOSCOPIC FIBEROPTIC CABLESeptember 6, 2002
K991208isolux americaENDOSCOPIC FIBEROPTIC CABLEJune 23, 1999
K983277cuda productsLIGHTSOURCE OR ILLUMINATOR MODEL I-100December 16, 1998
K933593progressive dynamicsLUMINOUS 150 FIBEROPTIC ILLUMINATOROctober 28, 1993
K922837endomedixS1500 XENON LIGHT SOURCENovember 3, 1992
K922462nextecNEXTEC FIBEROPTIC CABLESSeptember 21, 1992
K921866progressive dynamicsLUMINOUS 250 FIBEROPTIC ILLUMINATORJuly 8, 1992
K920167nextecNEXTEC FIBEROPTIC ILLUMINAT 150 WATT/HALO/3500 KELMarch 23, 1992
K904616storz instrumentSTORZ ULTRA-SOURCE HIGH OUTPUT ILLUMINATORApril 19, 1991
K904681vistekVLS 5300 300W XENON LIGHT SOURCEDecember 18, 1990
K904609medical dynamicsXENON LIGHT SOURCEDecember 18, 1990
K901108burtonFIBERLUMEMarch 28, 1990
K896549storz instrumentSTORZ FIBEROPTIC ENDO-ILLUMINATORSFebruary 15, 1990
K890398advanced surgical productsRYAN-STYLE DIRECTED INFUSION MANIPULATORFebruary 17, 1989
K883858advanced surgical productsFIBEROPTIC SHARP INTEGRAL PICK LIGHTPIPESeptember 29, 1988

FDA data resources