Light Guide Cable

FDA 510(k) K111342 · Schott North America

Substantially Equivalent

510(k) numberK111342

Submission

Device name
Light Guide Cable
Applicant
Schott North America
North Attleboro, MA, US
Received
May 13, 2011
Decision date
November 25, 2011
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
HBI – Illuminator, Fiberoptic, Surgical Field
Device class
Class II (moderate risk)
Regulation
21 CFR 878.4580
Specialty
General, Plastic Surgery

Other 510(k)s with product code HBI

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K223183Light-Guide CablesHBI · Traditional Olympus Winter & Ibe GmbH01/13/2023SE
K163185OptiLux LED IlluminatorHBI · Traditional Isolux, LLC11/21/2016SE
K141781Kogent Spetzler Lighted Suction TubesHBI · Traditional Katalyst Surgical, LLC04/09/2015SE
K0529791125 XSB Xenon Fiber-Optic Light SourceHBI · Traditional Isolux, LLC10/31/2005SE
K021931Endoscopic Fiberoptic CableHBI · Traditional Gulf Medical Fiberoptics09/06/2002SE
K991208Endoscopic Fiberoptic CableHBI · Traditional Isolux America06/23/1999SE
K983277Lightsource or Illuminator Model I-100HBI · Traditional Cuda Products Co.12/16/1998SE
K933593Luminous 150 Fiberoptic IlluminatorHBI · Traditional Progressive Dynamics, Inc.10/28/1993SE
K922837S1500 Xenon Light SourceHBI · Traditional Endomedix11/03/1992SE
K922462Nextec Fiberoptic CablesHBI · Traditional Nextec Corp.09/21/1992SE

Questions and answers

When was Light Guide Cable cleared by the FDA?

Light Guide Cable (K111342) received a 510(k) decision of Substantially Equivalent on November 25, 2011, 196 days after the submission was received.

What is the product code of K111342?

The FDA product code is HBI – Illuminator, Fiberoptic, Surgical Field, a Class II (moderate risk) device regulated under 21 CFR 878.4580.