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FTA — Light, Surgical, Accessories Class II

FDA Device Classification

Classification Details

Product Code
FTA
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
K150532key surgicalUniversal Light Handle Cover, Light Handle CoverSeptember 22, 2015
K142386litex manufacturingOperating Room Light Handle AdapterSeptember 29, 2014
K133554microtek medical, inc. an ecolabSURGICAL LIGHT HANDLE COVERApril 8, 2014
K133413black diamond videoIDSS SLCJanuary 7, 2014
K112133oasys healthcareOASYS SURGICAL LIGHT CONTROLLERMarch 1, 2012
K102791image stream medicalEASYSUITE SURGICAL LIGHT CONTROL (ESLC)November 23, 2010
K081698image stream medicalMAINSTREAM OR SURGICAL LIGHT CONTROL (MSLC)July 30, 2008
K053321xodus medicalLIGHT GUARD LIGHT HANDLE AND LIGHT HANDLE COVERJanuary 19, 2006
K051505karl storz endoscopy-americaSCB/STERIS OR-LIGHT INTERFACE BOXAugust 11, 2005
K023704karl storz endoscopy-americaKSEA SCB ACC CONTROLJanuary 30, 2003
K020640karl storz endoscopy-americaKSEA SCB MEDIA CONTROLMay 28, 2002
K020304aspen surgical productsDISPOSABLE LIGHT HANDLE AND ADAPTORFebruary 14, 2002
K993089deroyal cardiovascularDEROYAL DISPOSABLE RIGID LIGHT HANDLE AND ADAPTEROctober 14, 1999
K954940mdt biologicMDT STERIGRIP DISPOSABLE, SOFT COVER, LIGHT HANDLEJanuary 17, 1996
K935102burton medical productsSATURN LIGHTJune 27, 1994
K915068american medical mfgPLASTIC DISPOSABLE SURGICAL LIGHT HANDLE COVERFebruary 6, 1992
K901154microbio-medicsMICROTEK'S SURGICAL LAMP HANDLE & COVERMarch 20, 1990
K894397welconWELCON LIGHT HANDLEAugust 10, 1989
K890867transmedicalTC SYSTEM-COVERMarch 14, 1989
K890866transmedicalTC SYSTEM-HANDLEMarch 14, 1989