Light Source, Fiberoptic, Routine

Product Code: FCW

Gastroenterology/Urology General Optical Products / Medical

Applicable Standards: No Standard Applicable. General Radiological Health Requirements Apply. [1000-1005]

Code of Federal Regulations: 876.1500


Radiation TypeOptical
Radition SafetyNone
Annual ReportsNo

Products Classified as FCW

1760Light Source, Fiberoptic, RoutineEndoscope And Accessories.

Total Product Life Cycle (TPLC) Devices

1760Light Source, Fiberoptic, RoutineEndoscope And Accessories.

Pre-market Notifications for FCW

K131226NOVAPROBE LED LIGHT SOURCENOVAPROBE INCORPORATED
K123956POWER LED 175KARL STORZ ENDOSCOPY-AMERICA, INC.
K123359OVS1 VIDEO SYSTEMOLIVE MEDICAL CORP.
K121724ENDOLIGHT LED 1.1 ENDOLIGHTLED 1.2RICHARD WOLF MEDICAL INSTRUMENTS CORP.
K093792LED LIGHT SOURCESUNOPTIC TECHNOLOGIES, LLC
K091968KARL STORZ LED NOVA 100 COLD LIGHT FOUNTAIN, MODELS 2016020, 20161020CKARL STORZ ENDOSCOPY-AMERICA, INC.
K082813STRYKER LED LIGHTSOURCESTRYKER CORP.
K081477LUXTEC MLX LIGHT SOURCEINTEGRA LUXTEC, INC.
K032430ACUEITY MEDICAL LIGHT SOURCEACUEITY, INC.
K012265METAL HALIDE LIGHT SOURCE, MODELS MV-9088-T, MV-9088CIRCON VIDEO
K000229VIDEOLABS MEDCAM PROPLUS VIDEO CAMERA AND INTEGRAL LIGHT SOURCEVIDEOLABS, INC.
K993300COLDLIGHTSOURCE PL3000FIBER IMAGING TECHNOLOGIES, INC.
K99244750 W METAL HALIDE ILLUMINATOR, VES 0501.ANGIOLAZ, INC.
K970598INTEGRATED VISUALIZATION SYSTEMUROHEALTH, INC.
K964586PRESCOTT'S LIGHT SOURCE MODEL NO. II-150IBA/GRIFFITH

Global Unique Device Identification Database

00869836000307Light Source, Fiberoptic, Routine
00862658000302Light Source, Fiberoptic, Routine
00843059120424Light Source, Fiberoptic, Routine
00843059116991Light Source, Fiberoptic, Routine
00843059116694Light Source, Fiberoptic, Routine
00843059112351Light Source, Fiberoptic, Routine
00843059104493Light Source, Fiberoptic, Routine
00841645131984Light Source, Fiberoptic, Routine
00841645131977Light Source, Fiberoptic, Routine
00841645131960Light Source, Fiberoptic, Routine
00841645131953Light Source, Fiberoptic, Routine
00841645131946Light Source, Fiberoptic, Routine
00841645131939Light Source, Fiberoptic, Routine
00841645131922Light Source, Fiberoptic, Routine
00841645131915Light Source, Fiberoptic, Routine

Maude Adverse Events

PKG L9000 LIGHT SOURCESTRYKER ENDOSCOPY-SAN JOSE2020-03-30
ASSIACCURATE SURGICAL SCIENTIFIC INSTRUMENTS CORPORATION2020-03-27
RAD32" 4K/UHD MEDICAL DISPLAYDEPUY MITEK LLC US2020-03-19
PKG L9000 LIGHT SOURCESTRYKER ENDOSCOPY-SAN JOSE2020-03-18
FIBER OPTIC LIGHT CABLEKARL STORZ SE & CO. KG2020-03-16
RAD32" 4K/UHD MEDICAL DISPLAYDEPUY MITEK LLC US2020-03-13
PKG L9000 LIGHT SOURCESTRYKER ENDOSCOPY-SAN JOSE2020-03-09
PRIMARY MULTI-DIRECT MONITORMNTDEPUY MITEK LLC US2020-03-04
PKG L9000 LIGHT SOURCESTRYKER ENDOSCOPY-SAN JOSE2020-03-04
PKG, X8000 LIGHT SOURCESTRYKER ENDOSCOPY-SAN JOSE2020-02-27
INTEGRA LUXTEC MLX LIGHT SOURCE BOXINTEGRA LIFESCIENCES CORPORATION2020-02-26
EVOLUTION4KDEPUY MITEK LLC US2020-02-14
INTEGRA LUXTEC MLX LIGHT SOURCE BOXINTEGRA2020-02-04
PKG, X8000 LIGHT SOURCESTRYKER ENDOSCOPY-SAN JOSE2020-01-29
RAD32" 4K/UHD MEDICAL DISPLAYDEPUY MITEK LLC US2020-01-28
ALL-IN-ONE CCU+LIGHT ROWMEDOS INTERNATIONAL SàRL2020-01-21
ALL-IN-ONE CCU+LIGHT ROWMEDOS INTERNATIONAL SàRL2020-01-17
242326DEPUY MITEK LLC US2020-01-16
PKG L9000 LIGHT SOURCESTRYKER ENDOSCOPY-SAN JOSE2020-01-15
PKG L9000 LIGHT SOURCESTRYKER ENDOSCOPY-SAN JOSE2020-01-15
PKG L9000 LIGHT SOURCESTRYKER ENDOSCOPY-SAN JOSE2020-01-15
PKG L9000 LIGHT SOURCESTRYKER ENDOSCOPY-SAN JOSE2020-01-15
PKG L9000 LIGHT SOURCESTRYKER ENDOSCOPY-SAN JOSE2020-01-15
RAD32" 4K/UHD MEDICAL DISPLAYDEPUY MITEK LLC US2020-01-13
RADULTRA32"HDMEDICAL DISPLAYDEPUY MITEK LLC US2020-01-13
FUSLITEGU_OLYM-ACMI_3.5MMX3.0MMEDOS INTERNATIONAL SàRL2020-01-09
PKG, X8000 BULB MODULESTRYKER ENDOSCOPY-SAN JOSE2020-01-08
RAD32" 4K/UHD MEDICAL DISPLAYDEPUY MITEK LLC US2020-01-08
UNKNOWN_ENDOSCOPY_PRODUCTSTRYKER ENDOSCOPY-SAN JOSE2020-01-06
UNKNOWN_ENDOSCOPY_PRODUCTSTRYKER ENDOSCOPY-SAN JOSE2020-01-06
SYSTEM, LIGHT SOURCE, 500XL, ENGLISHSMITH & NEPHEW, INC.2020-01-02
PKG L9000 LIGHT SOURCESTRYKER ENDOSCOPY-SAN JOSE2019-12-19
ALL-IN-ONE CCU+LIGHT ROWMEDOS INTERNATIONAL SàRL2019-11-25
ALL-IN-ONE CCU+LIGHT ROWMEDOS INTERNATIONAL SàRL2019-11-25
ALL-IN-ONE CCU+LIGHT ROWMEDOS INTERNATIONAL SàRL2019-11-25
ALL-IN-ONE CCU+LIGHT ROWMEDOS INTERNATIONAL SàRL2019-11-25
STRYKER LIGHT CORDSTRYKER CORP.2019-11-20
MLX 300W XENON LIGHTSOURCEINTEGRA YORK, PA INC.2019-11-15
PKG, ADAPTER, RIGHT ANGLESTRYKER ENDOSCOPY-SAN JOSE2019-11-07
MLX 300W XENON LIGHTSOURCEINTEGRA YORK, PA INC.2019-11-01
LAMP MODULE REPLACEMENT MLXINTEGRA YORK, PA INC.2019-11-01
MLX 300W XENON LIGHTSOURCEINTEGRA YORK, PA INC.2019-10-25
ALL-IN-ONE CCU+LIGHT ROWMEDOS INTERNATIONAL SàRL2019-10-21
ALL-IN-ONE CCU+LIGHT SOURCEMEDOS INTERNATIONAL SàRL2019-10-18
ALL-IN-ONE CCU+LIGHT SOURCEMEDOS INTERNATIONAL SàRL2019-10-16
PKG L9000 LIGHT SOURCESTRYKER ENDOSCOPY-SAN JOSE2019-10-16
PKG L9000 LIGHT SOURCESTRYKER ENDOSCOPY-SAN JOSE2019-10-16
PKG L9000 LIGHT SOURCESTRYKER ENDOSCOPY-SAN JOSE2019-10-16
ALL-IN-ONE CCU+LIGHT ROWMEDOS INTERNATIONAL SàRL2019-10-15
IRIS URETERAL KITSTRYKER ENDOSCOPY-SAN JOSE2019-10-14
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