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510(k) K011693

TRUMPF SURGICAL LIGHTS, MODELS 301,501,701,1001 by Trumpf Medical Systems, Inc. — Product Code FSY

K011693 is an FDA 510(k) premarket notification submitted by Trumpf Medical Systems, Inc. for the device "TRUMPF SURGICAL LIGHTS, MODELS 301,501,701,1001". The FDA issued a decision of Substantially Equivalent on June 13, 2001. The device falls under product code FSY (Light, Surgical, Ceiling Mounted), a Class II device regulated under 21 CFR 878.4580.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 13, 2001
Date Received
May 31, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

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

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)
  • K132747 — VISUM BLADE LED SURGICAL LIGHTING SYSTEM (December 30, 2013)
  • K132307 — VIDA LED SURGICAL LIGHTING SYSTEM (November 5, 2013)
  • K131893 — AMICO CE SERIES SURGICAL LIGHTS, MIRA LED SERIES MINOR SURGICAL LIGHTS (October 30, 2013)

FDA data resources