Endobeam

FDA 510(k) K963044 · Corin USA

Substantially Equivalent

510(k) numberK963044

Submission

Device name
Endobeam
Applicant
Corin USA
Tampa, FL, US
Received
August 5, 1996
Decision date
September 20, 1996
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
GCT – Light Source, Endoscope, Xenon Arc
Device class
Class II (moderate risk)
Regulation
21 CFR 876.1500
Specialty
Gastroenterology, Urology

Other 510(k)s with product code GCT

510(k)DeviceApplicantDecision
K093125Alphaxenon Light 180 W and 300 WGCT · Abbreviated Gimmi GmbH01/27/2010SE
K082925XENON-100 SCB Light Source, Model 20132620GCT · Traditional KARL STORZ Endoscopy-America, Inc.12/18/2008SE
K070376Conmed Linvatec 300W Xenon Light SourceGCT · Traditional Conmed Linvatec08/20/2007SE
K040949Viaduct Miniscope and AccessoriesGCT · Traditional Acueity, Inc.05/07/2004SE
K022490Ksea Medi PackGCT · Traditional KARL STORZ Endoscopy-America, Inc.09/29/2003SE
K031994Linvatec 300W Xenon Light SourceGCT · Traditional Linvatec Corp.08/21/2003SE
K023468Endoscopic Light Source XL180/L3GCT · Traditional World of Medicine Lemke GmbH01/14/2003SE
K021717Endoscopic Light Source, Model XL300/L5GCT · Traditional World of Medicine Lemke GmbH08/20/2002SE
K020889Endoscopic Light Source XL202/L3GCT · Traditional World of Medicine Lemke GmbH06/05/2002SE
K013880Daylite Xenon Light SourcesGCT · Traditional Designs For Vision, Inc.12/07/2001SE

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Questions and answers

When was Endobeam cleared by the FDA?

Endobeam (K963044) received a 510(k) decision of Substantially Equivalent on September 20, 1996, 46 days after the submission was received.

What is the product code of K963044?

The FDA product code is GCT – Light Source, Endoscope, Xenon Arc, a Class II (moderate risk) device regulated under 21 CFR 876.1500.