BEUDAMED
    Product Code: GCT FDA class 2 21 CFR 876.1500

    Light Source, Endoscope, Xenon Arc

    Gastroenterology, Urology

    The Light Source, Endoscope, Xenon Arc (product code GCT) is a high-intensity xenon arc lamp used as an external light source to illuminate endoscopes, providing bright, white light for clear visualization during gastrointestinal or urological endoscopic procedures. It is classified as FDA Class 2, indicating moderate risk, subject to 510(k) requirements. The device is regulated under 21 CFR 876.1500 in the Gastroenterology, Urology specialty (GU). No special flags apply to this device.

    View on FDA
    510(k)s
    47
    FEI Numbers
    38
    Registration Numbers
    38
    Unique Applicants
    35
    Years Active
    30

    Research product code GCT in seconds

    The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Product Code
    GCT
    Device Class
    FDA class 2
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Review Panel
    GU
    Submission Type
    4

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    510(k) Clearance History

    Loading...

    Related 510(k) Clearances

    This FDA classification is associated with 47 510(k) clearances via K numbers.

    K Number Device Name
    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
    K992540 XENON LIGHT SOURCE PES 1
    K992050 LUMENON XENON LIGHT SOURCE
    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
    K952696 XENON LIGHT SOURCE MODEL 5121
    K952563 THE TULIP LCI-200 ILLUMINATION & IMAGING SYSTEM
    K951971 XENON LIGHT SOURCE
    K951895 ACCU-BEAM 300W 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

    FEI Numbers

    This FDA classification entry is associated with 38 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 38 registration numbers. Click on an entry to view related FDA registrations.