Visum Blade LED Surgical Lighting System

FDA 510(k) K132747 · Stryker Communications

Substantially Equivalent

510(k) numberK132747

Submission

Device name
Visum Blade LED Surgical Lighting System
Applicant
Stryker Communications
Flower Mound, TX, US
Received
September 3, 2013
Decision date
December 30, 2013
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
FSY – Light, Surgical, Ceiling Mounted
Device class
Class II (moderate risk)
Regulation
21 CFR 878.4580
Specialty
General, Plastic Surgery

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K140812MI-750 Procedural/Minor Surgical LightFSY · Traditional Medical Illumination International, Inc.08/07/2014SE
K132551ZF 720FSY · Traditional Umbel Corporation06/30/2014SE
K140930Vida LED Surgical Lighting System, V SeriesFSY · Traditional Convida Healthcare & Systems Corporation06/09/2014SE
K140461Mach LED 2MCFSY · Special Dr. Mach GmbH & Co. KG04/03/2014SE
K140460Mach LED 2SCFSY · Special Dr. Mach GmbH & Co. KG04/03/2014SE
K132307Vida LED Surgical Lighting SystemFSY · Traditional Convida Healthcare & Systems Corporation11/05/2013SE
K131893Amico Ce Series Surgical Lights, Mira LED Series Minor Surgical LightsFSY · Traditional Ajw Technology Consultants, Inc.10/30/2013SE
K122875Oricare L2700FSY · Traditional Oricare, Inc.12/18/2012SE

More from Oricare, Inc.

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K100852Stryker Switchpoint Infinity 3 Control System, Model: 067-8001-000OCS · Traditional 05/06/2010SE
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Questions and answers

When was Visum Blade LED Surgical Lighting System cleared by the FDA?

Visum Blade LED Surgical Lighting System (K132747) received a 510(k) decision of Substantially Equivalent on December 30, 2013, 118 days after the submission was received.

What is the product code of K132747?

The FDA product code is FSY – Light, Surgical, Ceiling Mounted, a Class II (moderate risk) device regulated under 21 CFR 878.4580.