FAKClass II
Panendoscope (gastroduodenoscope)
Gastroenterology, Urology · 21 CFR 876.1500
If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
MDR events4All time
Recalls0All time
Registered firms0Currently listed
510(k) clearances2All time
Recent MDR events
4 adverse event reports on file
- OLYMPUS EVIS DUODENOVIDEOSCOPEJul 29, 2010OtherOlympus Medical Systems Corporation8010047-2010-00152
- *Jun 18, 2009MalfunctionOlympus America, Inc.1407780
- OLYMPUSJul 1, 2008MalfunctionOlympus Medical Systems Corporation8010047-2008-00116
- OLYMPUSJun 27, 2008MalfunctionOlympus Medical Systems Corporation8010047-2008-00108
Event type breakdown
Malfunction3
Other1
Most-reported manufacturers
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
2 clearances for this product code