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
47 devices
25–47 of 47
Cleared Jul 25, 1995
XENON LIGHT SOURCE MODEL 5121
K952696
Richard Wolf Medical Instruments Corp.
Gastroenterology & Urology · 42d
Cleared May 24, 1995
ACCU-BEAM 300W XENON LIGHT SOURCE
K951895
Tti Medical
Gastroenterology & Urology · 30d
Cleared May 24, 1995
XENON LIGHT SOURCE
K951971
Envision Medical Corp.
Gastroenterology & Urology · 27d
Cleared Dec 13, 1994
MODEL 5135 AUTO LP/FLASH
K944607
Richard Wolf Medical Instruments Corp.
Gastroenterology & Urology · 85d
Cleared Nov 14, 1994
MODEL 5151
K944821
Richard Wolf Medical Instruments Corp.
Gastroenterology & Urology · 46d
Cleared Apr 22, 1994
KARL STORZ XENON LIGHT SOURCE MODEL 201320-20
K934559
KARL STORZ Endoscopy-America, Inc.
Gastroenterology & Urology · 218d
Cleared Apr 20, 1994
LCI-100 AND LCI-200 WELCH ALLYN ILLUMINATION AND IMAGING SYSTEM
K940270
Welch Allyn, Inc.
Gastroenterology & Urology · 89d
Cleared Apr 06, 1994
ZEISS SUPERLUX HIGH-INTENSITY LIGHT SOURCES
K936198
Carl Zeiss, Inc.
Gastroenterology & Urology · 98d
Cleared Feb 18, 1994
COGENT LIGHT ILLUMINATOR 10010 XENON LIGHT SOURCE
K933405
Cogent Light Technologies, Inc.
Gastroenterology & Urology · 221d
Cleared Jan 26, 1994
COOL LIGHT 300
K935423
Endosurgical Development Corp.
Gastroenterology & Urology · 78d
Cleared Nov 10, 1993
ANGIOLAZ VIDEO ENDOSCOPIC SYSTEM MODEL CAMLUM1 AND ACCESSORIES
K933868
Angiolaz, Inc.
Gastroenterology & Urology · 96d
Cleared Aug 06, 1993
VERRES NEEDLE
K932281
Surgeon Surgical Instrumentation, Inc.
Gastroenterology & Urology · 86d
Cleared Jul 06, 1993
XENON ENDOSCOPIC ILLUMINATOR, MODEL XEI-300
K924897
Medical Devices, Inc.
Gastroenterology & Urology · 280d
Cleared Jun 25, 1993
PENTAX XENON LIGHT SOURCE
K921315
Pentax Precision Instrument Corp.
Gastroenterology & Urology · 464d
Cleared Oct 05, 1992
SYSTEM 3000 XENON VIDEOLAP LIGHT
K923210
Cabot Medical Corp.
Gastroenterology & Urology · 96d
Cleared Jul 27, 1992
XENON LIGHT SOURCE AND ACCESSORIES
K921390
Coopervision Surgical
Gastroenterology & Urology · 126d
Cleared Oct 08, 1991
MARLOW VERRES NEEDLES
K913586
Marlo Surgical Technology
Gastroenterology & Urology · 57d
Cleared Aug 16, 1991
OLYMOUS XLS XENON LIGHT SOURCE
K912354
Perkinelmer Optoelectronics
Gastroenterology & Urology · 80d
Cleared Aug 14, 1991
ENDOSCOPIC LIGHT SOURCE
K911492
United States Endoscopy Group, Inc.
Gastroenterology & Urology · 132d
Cleared Mar 19, 1991
ENDOSCOPIC ACCESSORY TO THE LIGHT SOURCE
K905282
Frantz Medical Development, Ltd.
Gastroenterology & Urology · 116d
Cleared Jan 25, 1991
MULTIPLE IMAGING XENON ARC AUTO LIGH SOURCE
K905124
Red Wing Imaging, Inc.
Gastroenterology & Urology · 72d
Cleared Dec 24, 1986
THE KEYMED HI-LIGHT 250 LIGHT SOURCE
K864801
Keymed, Inc.
Gastroenterology & Urology · 15d
Cleared Dec 10, 1979
PENTEX UPPER G.I. SCOPE MODEL FG-28A
K792215
Pentax Precision Instrument Corp.
Gastroenterology & Urology · 35d