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510(k) K150532

Universal Light Handle Cover, Light Handle Cover by Key Surgical, Inc. — Product Code FTA

K150532 is an FDA 510(k) premarket notification submitted by Key Surgical, Inc. for the device "Universal Light Handle Cover, Light Handle Cover". The FDA issued a decision of Substantially Equivalent on September 22, 2015. The device falls under product code FTA (Light, Surgical, Accessories), a Class II device regulated under 21 CFR 878.4580. Key Surgical, Inc. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 22, 2015
Date Received
March 2, 2015
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 by Key Surgical, Inc.

  • K151222 — Cautery Tip Cleaner (May 22, 2015)
  • K910328 — KEY COMFORT GRIPS (March 6, 1991)
  • K896676 — KEY VASCULAR LOOPS (February 27, 1990)
  • K896472 — KEY VASCULAR BOOTIES (December 14, 1989)
  • K895591 — SILICONE INSTRUMENT SHODS (October 20, 1989)

Other clearances for product code FTA

  • K142386 — Operating Room Light Handle Adapter (September 29, 2014)
  • 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