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510(k) K142386

Operating Room Light Handle Adapter by Litex Manufacturing, Inc. — Product Code FTA

K142386 is an FDA 510(k) premarket notification submitted by Litex Manufacturing, Inc. for the device "Operating Room Light Handle Adapter". The FDA issued a decision of Substantially Equivalent on September 29, 2014. The device falls under product code FTA (Light, Surgical, Accessories), a Class II device regulated under 21 CFR 878.4580.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 29, 2014
Date Received
August 27, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Light, Surgical, Accessories
Device Class
Class II
Regulation Number
878.4580
Review Panel
SU
Submission Type

Other clearances for product code FTA

  • K150532 — Universal Light Handle Cover, Light Handle Cover (September 22, 2015)
  • K133554 — SURGICAL LIGHT HANDLE COVER (April 8, 2014)
  • K133413 — IDSS SLC (January 7, 2014)
  • K112133 — OASYS SURGICAL LIGHT CONTROLLER (March 1, 2012)
  • K102791 — EASYSUITE SURGICAL LIGHT CONTROL (ESLC) (November 23, 2010)
  • K081698 — MAINSTREAM OR SURGICAL LIGHT CONTROL (MSLC) (July 30, 2008)
  • K053321 — LIGHT GUARD LIGHT HANDLE AND LIGHT HANDLE COVER (January 19, 2006)
  • K051505 — SCB/STERIS OR-LIGHT INTERFACE BOX (August 11, 2005)
  • K023704 — KSEA SCB ACC CONTROL (January 30, 2003)
  • K020640 — KSEA SCB MEDIA CONTROL (May 28, 2002)

FDA data resources