FCRClass II
Light Source, Photographic, Fiberoptic
Gastroenterology, Urology · 21 CFR 876.1500
MDR events7All time
Recalls0All time
Registered firms7Currently listed
510(k) clearances3All time
Recent MDR events
7 adverse event reports on file
- XENON LIGHT SOURCE/FLASHFeb 26, 2019MalfunctionKarl Storz Endoscopy-america, Inc.8369613
- *Dec 19, 2013MalfunctionKarl Storz Endoscopy-america, Inc.3537486
- DYONICSJan 19, 2001OtherSmith & Nephew Dyonics313183
- AUTO-IRIS FIBER LIGHT PROJECTORMay 22, 1997MalfunctionRichard Wolf Medical Instrume.1418479-1997-00025
- AUTO-IRIS FIBER LIGHT PROJECTORMay 22, 1997MalfunctionRichard Wolf Medical Instrume.1418479-1997-00024
- LIGHT CORDApr 23, 1997OtherRichard Wolf Medical Instruments Corp.MW1011182
- LIGHT SOURCE, FIBEROPTICNov 11, 1994MalfunctionRichard Wolf9805
Event type breakdown
Malfunction5
Other2
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
7 firms currently registered for this product code
Karl Storz Endovision, Inc.
CHARLTON, MA, US
Healthium Medtech Limited
BANGALORE Karnataka, IN
Karl Storz Se & Co Kg
TUTTLINGEN Baden-Wurttemberg, DE
Gyrus Acmi, Inc.
Brooklyn Park, MN, US
Karl Storz Endoscopy-america, Inc.
Auburn, MA, US
Karl Storz Endoscopy-america, Inc.
El Segundo, CA, US
Sunoptic Technologies, Llc
JACKSONVILLE, FL, US
510(k) clearances
3 clearances for this product code