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510(k) K132747

VISUM BLADE LED SURGICAL LIGHTING SYSTEM by Stryker Communications — Product Code FSY

K132747 is an FDA 510(k) premarket notification submitted by Stryker Communications for the device "VISUM BLADE LED SURGICAL LIGHTING SYSTEM". The FDA issued a decision of Substantially Equivalent on December 30, 2013. The device falls under product code FSY (Light, Surgical, Ceiling Mounted), a Class II device regulated under 21 CFR 878.4580. Stryker Communications has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 30, 2013
Date Received
September 3, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

Other clearances by Stryker Communications

  • K100852 — STRYKER SWITCHPOINT INFINITY 3 CONTROL SYSTEM, MODEL: 067-8001-000 (May 6, 2010)
  • K060802 — VISUM LED SURGICAL LIGHTING SYSTEM (April 7, 2006)
  • K033132 — STRYKER SWITCHPOINT INFINITY (September 2, 2004)

Other clearances for product code FSY

  • K142984 — Leo Minor (October 29, 2014)
  • K142076 — CLAVEGUARD FREEDOM SURGICAL LIGHT (September 30, 2014)
  • K140812 — MI-750 PROCEDURAL/MINOR SURGICAL LIGHT (August 7, 2014)
  • K132551 — ZF 720 (June 30, 2014)
  • K140930 — VIDA LED SURGICAL LIGHTING SYSTEM, V SERIES (June 9, 2014)
  • K140461 — MACH LED 2MC (April 3, 2014)
  • K140460 — MACH LED 2SC (April 3, 2014)
  • K132307 — VIDA LED SURGICAL LIGHTING SYSTEM (November 5, 2013)
  • K131893 — AMICO CE SERIES SURGICAL LIGHTS, MIRA LED SERIES MINOR SURGICAL LIGHTS (October 30, 2013)
  • K122875 — ORICARE L2700 (December 18, 2012)

FDA data resources