GDBClass II
Endoscope, Fiber Optic
Gastroenterology, Urology · 21 CFR 876.1500
MDR events27All time
Recalls0All time
Registered firms0Currently listed
510(k) clearances7All time
Recent MDR events
27 adverse event reports on file
- PENTAXNov 13, 2020MalfunctionHoya Corporation Pentax Tokyo Office9610877-2020-00214
- FUJINONApr 11, 2017MalfunctionFujifilm Medical Systems U.s.a., Inc.6479948
- *Nov 18, 2013*3485604
- OLYMPUS ENDOSCOPESJun 1, 2012OtherOlympus Medical Systems Corporation8010047-2012-00170
- OLYMPUS ENDOSCOPESDec 8, 2011OtherOlympus Medical Systems Corporation8010047-2011-00309
- OLYMPUS BALLOON 3 FOR ULTRASONIC ENDOSCOPEJul 15, 2011MalfunctionOlympus Medical Systems Corp.8010047-2011-00158
- OLYMPUS ENDOSCOPESFeb 8, 2011OtherOlympus Medical System Corporation8010047-2011-00020
- OLYMPUS ULTRASOUND BALLOON CUFFNov 23, 2010MalfunctionOlympus Medical Systems Corporation8010047-2010-00236
- OLYMPUS ENDOSCOPESMar 8, 2010OtherOlympus Medical Systems Corporation8010047-2010-00041
- OLYMPUS ENDOSCOPEJan 20, 2010OtherOlympus Medical Systems Corporation8010047-2010-00011
Event type breakdown
Malfunction11
Injury9
Other5
Unspecified2
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
0 firms currently registered for this product code
No registered firms found for this product code.
510(k) clearances
7 clearances for this product code
- Designs For Vision, Inc.Aug 20, 2003
K032283 · DESIGNS FOR VISION FIBEROPTIC LIGHT
- Matrix Medica, Inc.Sep 18, 1996
K961536 · FLEXSCOPE
- Cuda Products Co.Jul 13, 1994
K935818 · ENDOSCOPE
- Olympus Corp.Nov 15, 1988
K882061 · OLYMPUS GF-UM3/EU-M3
- RegtecFeb 19, 1986
K855151 · FRITCH OPHTHALMIC ENDOSCOPE
- Medical Diagnostics, Ca.Dec 6, 1984
K843900 · FOCUSCOPE UNIVERSAL SYSTEM
- Pentax Precision Instrument Corp.Jan 15, 1981
K810007 · PENTAX UPPER G.I. FIBERSCOPE, #FG-34