Product code GCT— Gastroenterology, Urology
ACCU-BEAM 300W XENON LIGHT SOURCE
- Classification name
- Light Source, Endoscope, Xenon Arc
- Device class
- Class 2
- Regulation
- 21 CFR 876.1500
- Advisory panel
- Gastroenterology, Urology
- Total cleared
- 47
- First cleared
- Most recent
Market context for product code GCT
FDA has cleared devices under product code GCT between 1979 and 2010, filed by 34 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
last 15 years- 2010
- 2008
- 2007
- 2004
- 2003
- 2002
- 2001
- 1999
- 1998
- 1997
- 1996
- 1995
- 1994
- 1993
- 1992
Top applicants under product code GCT
- Richard Wolf Medical Instruments Corp.
- KARL STORZ Endoscopy-America, Inc.
- World of Medicine Lemke GmbH
- Welch Allyn, Inc.
- Pentax Precision Instrument Corp.
- Laser Optik Systeme GmbH & Co. KG
- Contec Medical Vision, Ltd.
- Cogent Light Technologies, Inc.
- Walter Lorenz Surgical, Inc.
- United States Endoscopy Group, Inc.
Adverse events under product code GCT
product code GCT- Malfunction
- 1,393
- Other
- 2
- Total
- 1,395
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recent clearances under product code GCT
- K093125 — ALPHAXENON LIGHT 180 W AND 300 W
- K082925 — XENON-100 SCB LIGHT SOURCE, MODEL 20132620
- K070376 — CONMED LINVATEC 300W XENON LIGHT SOURCE
- K040949 — VIADUCT MINISCOPE AND ACCESSORIES
- K022490 — KSEA MEDI PACK
- K031994 — LINVATEC 300W XENON LIGHT SOURCE
- K023468 — ENDOSCOPIC LIGHT SOURCE XL180/L3
- K021717 — ENDOSCOPIC LIGHT SOURCE, MODEL XL300/L5
- K020889 — ENDOSCOPIC LIGHT SOURCE XL202/L3
- K013880 — DAYLITE XENON LIGHT SOURCES
- K992050 — LUMENON XENON LIGHT SOURCE
- K992540 — XENON LIGHT SOURCE PES 1
- K983628 — XENON LIGHT SOURCE AUTO LIP 5123, MODEL 2123.011
- K982962 — XENON LIGHT SOURCE, MODELS LS6180, LS6035
- K981804 — XENON LIGHT SOURCE MODEL LS6000
- K980281 — WELCH ALLYN XENON 300 LIGHT SOURCE
- K971057 — COGENLIGHT TECHNOLOGIES XLS ILLUMINATOR SYSTEM
- K963227 — WHITE SUN LIGHT SOURCE MODEL #: XL300 AND #: XL175
- K963044 — ENDOBEAM
- K962365 — XENON LIGHTSOURCE
- K954561 — XENON NOPPVA
- K953924 — XLS-300 XENON LIGHT SOURCE
- K952028 — COLD LIGHT SOURCE LOS XL-A 100
- K952563 — THE TULIP LCI-200 ILLUMINATION & IMAGING SYSTEM
- K952696 — XENON LIGHT SOURCE MODEL 5121
- K951895 — ACCU-BEAM 300W XENON LIGHT SOURCE
- K951971 — XENON LIGHT SOURCE
- K944607 — MODEL 5135 AUTO LP/FLASH
- K944821 — MODEL 5151
- K934559 — KARL STORZ XENON LIGHT SOURCE MODEL 201320-20
- K940270 — LCI-100 AND LCI-200 WELCH ALLYN ILLUMINATION AND IMAGING SYSTEM
- K936198 — ZEISS SUPERLUX HIGH-INTENSITY LIGHT SOURCES
- K933405 — COGENT LIGHT ILLUMINATOR 10010 XENON LIGHT SOURCE
- K935423 — COOL LIGHT 300
- K933868 — ANGIOLAZ VIDEO ENDOSCOPIC SYSTEM MODEL CAMLUM1 AND ACCESSORIES
- K932281 — VERRES NEEDLE
- K924897 — XENON ENDOSCOPIC ILLUMINATOR, MODEL XEI-300
- K921315 — PENTAX XENON LIGHT SOURCE
- K923210 — SYSTEM 3000 XENON VIDEOLAP LIGHT
- K921390 — XENON LIGHT SOURCE AND ACCESSORIES
- K913586 — MARLOW VERRES NEEDLES
- K912354 — OLYMOUS XLS XENON LIGHT SOURCE
- K911492 — ENDOSCOPIC LIGHT SOURCE
- K905282 — ENDOSCOPIC ACCESSORY TO THE LIGHT SOURCE
- K905124 — MULTIPLE IMAGING XENON ARC AUTO LIGH SOURCE
- K864801 — THE KEYMED HI-LIGHT 250 LIGHT SOURCE
- K792215 — PENTEX UPPER G.I. SCOPE MODEL FG-28A
Data sourced from openFDA. This site is unofficial and independent of the FDA.