FDA 510(k) Applications for Medical Device Product Code "FTA"
(Light, Surgical, Accessories)

FDA 510(k) Number Applicant Device Name Decision Date
K020304 ASPEN SURGICAL PRODUCTS, INC. DISPOSABLE LIGHT HANDLE AND ADAPTOR 02/14/2002
K133413 BLACK DIAMOND VIDEO IDSS SLC 01/07/2014
K993089 DEROYAL CARDIOVASCULAR, INC. DEROYAL DISPOSABLE RIGID LIGHT HANDLE AND ADAPTER 10/14/1999
K102791 IMAGE STREAM MEDICAL, INC. EASYSUITE SURGICAL LIGHT CONTROL (ESLC) 11/23/2010
K081698 IMAGE STREAM MEDICAL, INC. MAINSTREAM OR SURGICAL LIGHT CONTROL (MSLC) 07/30/2008
K023704 KARL STORZ ENDOSCOPY-AMERICA, INC. KSEA SCB ACC CONTROL 01/30/2003
K020640 KARL STORZ ENDOSCOPY-AMERICA, INC. KSEA SCB MEDIA CONTROL 05/28/2002
K051505 KARL STORZ ENDOSCOPY-AMERICA, INC. SCB/STERIS OR-LIGHT INTERFACE BOX 08/11/2005
K150532 Key Surgical, Inc. Universal Light Handle Cover, Light Handle Cover 09/22/2015
K142386 Litex Manufacturing, Inc. Operating Room Light Handle Adapter 09/29/2014
K954940 MDT BIOLOGIC CO. MDT STERIGRIP DISPOSABLE, SOFT COVER, LIGHT HANDLE 01/17/1996
K133554 MICROTEK MEDICAL, INC. AN ECOLAB COMPANY SURGICAL LIGHT HANDLE COVER 04/08/2014
K112133 OASYS HEALTHCARE OASYS SURGICAL LIGHT CONTROLLER 03/01/2012
K053321 XODUS MEDICAL, INC. LIGHT GUARD LIGHT HANDLE AND LIGHT HANDLE COVER 01/19/2006


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