Led Light Source
Gastroenterology, Urology · 21 CFR 876.1500
Used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals
Recent MDR events
271 adverse event reports on file
- Light source "EndoLED", for flexible endoscopesJul 29, 2026MalfunctionOlympus Winter & Ibe Gmbh9610773-2026-05211
- COLD LIGHT FOUNTAIN POWER LED 300Jul 14, 2026MalfunctionKarl Storz Se & Co. Kg9610617-2026-01612
- LIGHT SOURCE "ENDOLED", FOR FLEXIBLE ENDOSCOPESJul 13, 2026MalfunctionOlympus Winter & Ibe Gmbh9610773-2026-04880
- LIGHT SOURCE "ENDOLED", FOR FLEXIBLE ENDOSCOPESJul 9, 2026MalfunctionOlympus Winter & Ibe Gmbh9610773-2026-04821
- COLD LIGHT FOUNTAIN POWER LED 300Jun 8, 2026MalfunctionKarl Storz Se & Co. Kg9610617-2026-01315
- LIGHT SOURCE "ENDOLED", FOR FLEXIBLE ENDOSCOPESJun 6, 2026MalfunctionOlympus Winter & Ibe Gmbh9610773-2026-04307
- SPYGLASS DISCOVER DIGITAL CONTROLLERMay 27, 2026MalfunctionEnercon Technologies3005099803-2026-02141
- LIGHT SOURCE "ENDOLED", FOR FLEXIBLE ENDOSCOPESMay 12, 2026MalfunctionOlympus Winter & Ibe Gmbh9610773-2026-03702
- LIGHT SOURCE "ENDOLED", FOR FLEXIBLE ENDOSCOPESMay 1, 2026MalfunctionOlympus Winter & Ibe Gmbh9610773-2026-03449
- LIGHT SOURCE "ENDOLED", FOR FLEXIBLE ENDOSCOPESApr 29, 2026MalfunctionOlympus Winter & Ibe Gmbh9610773-2026-03389
Event type breakdown
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
125 firms currently registered for this product code
Scivita Medical Technology Co., Ltd.
suzhou Jiangsu, CN
M.i.one Co.,ltd.
Wonju-si Gangwon, KR
Firefly Global
Belmont, MA, US
Conmed Corporation
Utica, NY, US
Cook Incorporated
Spencer, IN, US
Enercon Technologies
GRAY, ME, US
Vitalcor, Inc.
WESTMONT, IL, US
Boston Scientific Corporation
Marlborough, MA, US
Synergy Health Ast, Srl
Alajuela, CR
Mka Medikal Ic Ve Dis Ticaret Sanayi Limited Sirketi
Cankaya Ankara, TR
Boston Scientific Limited
GALWAY, IE
Aizu Olympus Co., Ltd.
AIZUWAKAMATSU-SHI Fukushima, JP
Boston Scientific Limited
CLONMEL Tipperary, IE
Ecleris Srl
Villa Martelli Buenos Aires, AR
Invidia Medical Gmbh U Co Kg
Emmingen-Liptingen Baden-Wurttemberg, DE
Shanghai Seegen Photoelectric Technology Co., Ltd
Shanghai, CN
Olympus Medical Systems Corp.
HACHIOJI-SHI Tokyo, JP
Endonest Medical Systems Llp
PALGHAR Maharashtra, IN
Br Surgical Llc
Jacksonville, FL, US
Optim Llc
Sturbridge, MA, US
Intuitive Surgical, Inc.
Santa Clara, CA, US
Karl Storz Endoscopy-america, Inc.
Auburn, MA, US
Karl Storz Endoscopy Canada Ltd.
Mississauga Ontario, CA
Karl Storz Se & Co. Kg
NEUHAUSEN OBECK Baden-Wurttemberg, DE
Karl Storz Se & Co. Kg
TUTTLINGEN Baden-Wurttemberg, DE
510(k) clearances
9 clearances for this product code
- Quest Medical ImagingMar 16, 2015
K141164 · ARTEMIS LIGHT ENGINE
- Olympus Winter & Ibe GmbHJul 30, 2014
K133311 · ENDOLED
- Olympus Winter & Ibe GmbHJun 19, 2013
K130819 · CLL- V1 LIGHT SOURCE
- Olympus Medical Systems Corp.Dec 14, 2012
K122831 · VIDEO SYSTEM CENTER
- Maquet S.A.S.Jan 12, 2012
K113679 · LUCEA LED SURGICAL LIGHT SYSTEM
- SoproMar 22, 2011
K103813 · SOPRO 281
- Fiberoptics Technology, Inc.Aug 17, 2010
K102167 · LO-50 LED LIGHT SOURCE
- Optim, Inc.Jul 28, 2009
K091829 · PLS PORTABLE LIGHT SOURCE