Illuminator, Fiberoptic, Surgical Field
General, Plastic Surgery · 21 CFR 878.4580
Recent MDR events
58 adverse event reports on file
- LIGHT-GUIDE CABLE, 4.25 MM, 3 M, CF TYPEMar 13, 2026InjuryOlympus Winter & Ibe Gmbh9610773-2026-01867
- LIGHT-GUIDE CABLE, 2.8 MM, 3 M, CF TYPEFeb 25, 2026MalfunctionOlympus Winter & Ibe Gmbh9610773-2026-01453
- LIGHT-GUIDE CABLE, 2.8 MM, 3 M, CF TYPEFeb 20, 2026InjuryOlympus Winter & Ibe Gmbh9610773-2026-01267
- LIGHT-GUIDE CABLE, 2.8 MM, 3 M, CF TYPEFeb 11, 2026InjuryOlympus Winter & Ibe Gmbh9610773-2026-00989
- OLYMPUS LIGHT CORDMar 26, 2025MalfunctionGyrus Acmi, Inc.MW5168250
- LIGHT-GUIDE CABLE, 4.25 MM, 3 M, CF TYPEMay 16, 2024MalfunctionOlympus Winter & Ibe Gmbh9610773-2024-01260
- LIGHT-GUIDE CABLE, 2.8 MM, 3 M, CF TYPEMar 19, 2024MalfunctionOlympus Winter & Ibe Gmbh9610773-2024-00767
- LIGHT-GUIDE CABLE, 4.25 MM, 3 M, CF TYPEApr 7, 2023MalfunctionOlympus Winter & Ibe Gmbh9610773-2023-01001
- LIGHT-GUIDE CABLE, 2.8 MM, 3 M, CF TYPEDec 21, 2022InjuryOlympus Winter & Ibe Gmbh9610773-2022-00708
- LIGHT-GUIDE CABLE, 2.8 MM, 3 M, CF TYPEMar 11, 2022MalfunctionOlympus Winter & Ibe Gmbh9611174-2022-00014
Event type breakdown
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
28 firms currently registered for this product code
Midwest Sterilization Corp.
JACKSON, MO, US
Bausch & Lomb Incorporated
Rochester, NY, US
Sterigenics U.s., Llc
Ontario, CA, US
Arvato Se
Hamburg, DE
Medical Illumination International, Inc
Chatsworth, CA, US
Bausch & Lomb Incorporated
Saint Louis, MO, US
Primo Medical Group, Inc
W Bridgewater, MA, US
Teleflex Medical Llc
Morrisville, NC, US
Stryker Instruments
Portage, MI, US
American Medical Endoscopy
Doral, FL, US
Primo Medical Group, Inc
STOUGHTON, MA, US
Nico Corporation
Indianapolis, IN, US
Gulf Fiberoptics, Inc.
OLDSMAR, FL, US
Covidien
TIJUANA, B.C. Mexico, MX
Katalyst Surgical, Llc
Chesterfield, MO, US
Gyrus Acmi, Inc.
Brooklyn Park, MN, US
Medtronic Engineering And Innovation Center (meic)
Hyderabad Telangana, IN
Covidien
North Haven, CT, US
Sterigenics Us Llc
Los Angeles, CA, US
Olympus Winter & Ibe Gmbh
HAMBURG, DE
Schott Cr, S.r.o.
Valasske Mezirici Zlinsky Kraj, CZ
510(k) clearances
28 clearances for this product code
- Olympus Winter & Ibe GmbHJan 13, 2023
K223183 · Light-Guide Cables
- Isolux, LLCNov 21, 2016
K163185 · OptiLux LED Illuminator
- Katalyst Surgical, LLCApr 9, 2015
K141781 · KOGENT SPETZLER LIGHTED SUCTION TUBES
- Schott North AmericaNov 25, 2011
K111342 · LIGHT GUIDE CABLE
- Isolux, LLCOct 31, 2005
K052979 · 1125 XSB XENON FIBER-OPTIC LIGHT SOURCE
- Gulf Medical FiberopticsSep 6, 2002
K021931 · ENDOSCOPIC FIBEROPTIC CABLE
- Isolux AmericaJun 23, 1999
K991208 · ENDOSCOPIC FIBEROPTIC CABLE
- Cuda Products Co.Dec 16, 1998
K983277 · LIGHTSOURCE OR ILLUMINATOR MODEL I-100