GCT · Class II · 21 CFR 876.1500

FDA Product Code GCT: Light Source, Endoscope, Xenon Arc

Leading manufacturers include Richard Wolf Medical Instruments Corp., KARL STORZ Endoscopy-America, Inc. and World of Medicine Lemke GmbH.

47
Total
47
Cleared
94d
Avg days
1979
Since

FDA 510(k) Cleared Light Source, Endoscope, Xenon Arc Devices (Product Code GCT)

47 devices
1–24 of 47
Cleared Jan 27, 2010
ALPHAXENON LIGHT 180 W AND 300 W
K093125
Gimmi GmbH
Gastroenterology & Urology · 117d
Cleared Dec 18, 2008
XENON-100 SCB LIGHT SOURCE, MODEL 20132620
K082925
KARL STORZ Endoscopy-America, Inc.
Gastroenterology & Urology · 78d
Cleared Aug 20, 2007
CONMED LINVATEC 300W XENON LIGHT SOURCE
K070376
Conmed Linvatec
Gastroenterology & Urology · 193d
Cleared May 07, 2004
VIADUCT MINISCOPE AND ACCESSORIES
K040949
Acueity, Inc.
Gastroenterology & Urology · 25d
Cleared Sep 29, 2003
KSEA MEDI PACK
K022490
KARL STORZ Endoscopy-America, Inc.
Gastroenterology & Urology · 427d
Cleared Aug 21, 2003
LINVATEC 300W XENON LIGHT SOURCE
K031994
Linvatec Corp.
Gastroenterology & Urology · 55d
Cleared Jan 14, 2003
ENDOSCOPIC LIGHT SOURCE XL180/L3
K023468
World of Medicine Lemke GmbH
Gastroenterology & Urology · 90d
Cleared Aug 20, 2002
ENDOSCOPIC LIGHT SOURCE, MODEL XL300/L5
K021717
World of Medicine Lemke GmbH
Gastroenterology & Urology · 89d
Cleared Jun 05, 2002
ENDOSCOPIC LIGHT SOURCE XL202/L3
K020889
World of Medicine Lemke GmbH
Gastroenterology & Urology · 78d
Cleared Dec 07, 2001
DAYLITE XENON LIGHT SOURCES
K013880
Designs For Vision, Inc.
Gastroenterology & Urology · 14d
Cleared Sep 14, 1999
LUMENON XENON LIGHT SOURCE
K992050
Walter Lorenz Surgical, Inc.
Gastroenterology & Urology · 89d
Cleared Sep 14, 1999
XENON LIGHT SOURCE PES 1
K992540
Laser Optik Systeme GmbH & Co. KG
Gastroenterology & Urology · 47d
Cleared Dec 11, 1998
XENON LIGHT SOURCE AUTO LIP 5123, MODEL 2123.011
K983628
Richard Wolf Medical Instruments Corp.
Gastroenterology & Urology · 57d
Cleared Sep 23, 1998
XENON LIGHT SOURCE, MODELS LS6180, LS6035
K982962
Contec Medical Vision, Ltd.
Gastroenterology & Urology · 30d
Cleared Jul 24, 1998
XENON LIGHT SOURCE MODEL LS6000
K981804
Contec Medical Vision, Ltd.
Gastroenterology & Urology · 64d
Cleared Feb 27, 1998
WELCH ALLYN XENON 300 LIGHT SOURCE
K980281
Welch Allyn, Inc.
Gastroenterology & Urology · 32d
Cleared Mar 28, 1997
COGENLIGHT TECHNOLOGIES XLS ILLUMINATOR SYSTEM
K971057
Cogent Light Technologies, Inc.
Gastroenterology & Urology · 4d
Cleared Oct 23, 1996
WHITE SUN LIGHT SOURCE MODEL #: XL300 AND #: XL175
K963227
Products For Medicine
Gastroenterology & Urology · 65d
Cleared Sep 20, 1996
ENDOBEAM
K963044
Corin USA
Gastroenterology & Urology · 46d
Cleared Jul 18, 1996
XENON LIGHTSOURCE
K962365
Dsp Worldwide
Gastroenterology & Urology · 29d
Cleared Oct 19, 1995
XENON NOPPVA
K954561
KARL STORZ Endoscopy-America, Inc.
Gastroenterology & Urology · 17d
Cleared Sep 21, 1995
XLS-300 XENON LIGHT SOURCE
K953924
Specialties of Surgery
Gastroenterology & Urology · 34d
Cleared Jul 27, 1995
COLD LIGHT SOURCE LOS XL-A 100
K952028
Laser Optik Systeme GmbH & Co. KG
Gastroenterology & Urology · 87d
Cleared Jul 25, 1995
THE TULIP LCI-200 ILLUMINATION & IMAGING SYSTEM
K952563
The Tulip Mfg. Co.
Gastroenterology & Urology · 53d

About Product Code GCT - Regulatory Context