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510(k) K053321

LIGHT GUARD LIGHT HANDLE AND LIGHT HANDLE COVER by Xodus Medical, Inc. — Product Code FTA

K053321 is an FDA 510(k) premarket notification submitted by Xodus Medical, Inc. for the device "LIGHT GUARD LIGHT HANDLE AND LIGHT HANDLE COVER". The FDA issued a decision of Substantially Equivalent on January 19, 2006. The device falls under product code FTA (Light, Surgical, Accessories), a Class II device regulated under 21 CFR 878.4580. Xodus Medical, Inc. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 19, 2006
Date Received
November 30, 2005
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 Xodus Medical, Inc.

  • K260903 — Hot Pink Pad Warming System (April 16, 2026)
  • K182080 — Scope Antifogging System (September 19, 2018)
  • K081647 — ELECTROSURGICAL PENCIL WITH PTFE COATED & UNCOATED ELECTRODE TIPS (August 12, 2008)
  • K063587 — XODUS MEDICAL ANTI-FOG SOLUTION (January 9, 2007)
  • K053433 — CAUTERY TIP CLEANER, MODEL 30500 (January 19, 2006)

Other clearances for product code FTA

  • K150532 — Universal Light Handle Cover, Light Handle Cover (September 22, 2015)
  • 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)
  • 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