PGUClass II
Spatial Imaging For Display Of Endoscope Position
Gastroenterology, Urology · 21 CFR 876.1500
To detect and display the shape of an inserted endoscope.
MDR events6All time
Recalls0All time
Registered firms3Currently listed
510(k) clearances1All time
Recent MDR events
6 adverse event reports on file
- ENDOSCOPE POSITION DETECTING UNITJul 20, 2026MalfunctionShirakawa Olympus Co., Ltd.3002808148-2026-24654
- ENDOSCOPE POSITION DETECTING UNITAug 24, 2023MalfunctionShirakawa Olympus Co., Ltd.3002808148-2023-08873
- ENDOSCOPE POSITION DETECTING UNITJun 8, 2023MalfunctionShirakawa Olympus Co., Ltd.3002808148-2023-05751
- ENDOSCOPE POSITION DETECTING UNITNov 4, 2022MalfunctionShirakawa Olympus Co., Ltd.3002808148-2022-03841
- ENDOSCOPE POSITION DETECTING UNITOct 21, 2022MalfunctionShirakawa Olympus Co., Ltd.3002808148-2022-03418
- ENDOSCOPE POSITION DETECTING UNITOct 16, 2017InjuryOlympus Medical Systems Corp.8010047-2017-01475
Event type breakdown
Malfunction5
Injury1
Most-reported manufacturers
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
3 firms currently registered for this product code
510(k) clearances
1 clearances for this product code