FCW — Light Source, Fiberoptic, Routine Class II

FDA Device Classification

Classification Details

Product Code
FCW
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
K131226novaprobe incorporatedNOVAPROBE LED LIGHT SOURCEJuly 24, 2014
K123956karl storz endoscopy-americaPOWER LED 175January 25, 2013
K123359olive medicalOVS1 VIDEO SYSTEMDecember 19, 2012
K121724richard wolf medical instrumentsENDOLIGHT LED 1.1 ENDOLIGHTLED 1.2September 20, 2012
K093792sunoptic technologiesLED LIGHT SOURCEMarch 18, 2010
K091968karl storz endoscopy-americaKARL STORZ LED NOVA 100 COLD LIGHT FOUNTAIN, MODELS 2016020, 20161020CSeptember 14, 2009
K082813strykerSTRYKER LED LIGHTSOURCEDecember 19, 2008
K081477integra luxtecLUXTEC MLX LIGHT SOURCEJune 18, 2008
K032430acueityACUEITY MEDICAL LIGHT SOURCESeptember 5, 2003
K012265circon videoMETAL HALIDE LIGHT SOURCE, MODELS MV-9088-T, MV-9088October 17, 2001
K000229videolabsVIDEOLABS MEDCAM PROPLUS VIDEO CAMERA AND INTEGRAL LIGHT SOURCEMarch 21, 2000
K993300fiber imaging technologiesCOLDLIGHTSOURCE PL3000November 5, 1999
K992447angiolaz50 W METAL HALIDE ILLUMINATOR, VES 0501.October 20, 1999
K970598urohealthINTEGRATED VISUALIZATION SYSTEMMarch 12, 1997
K964586iba/griffithPRESCOTT'S LIGHT SOURCE MODEL NO. II-150January 17, 1997
K963043corin usaENDOSPOTSeptember 20, 1996
K951647welch allynWELCH ALLYN HI - LUX ILLUMINATORMay 17, 1995
K945420stephen chakoffCHAKOFF ENDOSCOPYDecember 8, 1994
K942155servicetrendsHMT ENDOSCREEN, MODEL ESC 501July 1, 1994
K934531united states surgical, a division of tyco healthcAUTO SUTURE DISPOSABLE LIGHT CABLEMay 18, 1994