Endoscopic Accessory to the Light Source

FDA 510(k) K905282 · Frantz Medical Development, Ltd.

Unknown

510(k) numberK905282

Submission

Device name
Endoscopic Accessory to the Light Source
Applicant
Frantz Medical Development, Ltd.
New York, NY, US
Received
November 23, 1990
Decision date
March 19, 1991
Decision
Unknown (SEKD)
Type
Traditional 510(k)

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

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K093125Alphaxenon Light 180 W and 300 WGCT · Abbreviated Gimmi GmbH01/27/2010SE
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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

More from Designs For Vision, Inc.

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K873119Flexiflo Companion Enteral Nutrition PumpLZH · Traditional 11/05/1987SE
K871710Biopsy ForcepsFCL · Traditional 08/10/1987SE
K863508Frantz Medical ElectrodeDXR · Traditional 02/06/1987SE

Questions and answers

When was Endoscopic Accessory to the Light Source cleared by the FDA?

Endoscopic Accessory to the Light Source (K905282) received a 510(k) decision of Unknown on March 19, 1991, 116 days after the submission was received.

What is the product code of K905282?

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