PGDClass II
Colon Capsule Imaging System
Gastroenterology, Urology · 21 CFR 876.1330
visualization of the colon for the detection of polyps
MDR events14All time
Recalls0All time
Registered firms6Currently listed
510(k) clearances2All time
Recent MDR events
14 adverse event reports on file
- PILL CAMJul 25, 2025InjuryUnknownMW5173341
- PILLCAMOct 25, 2024InjuryGiven Imaging Ltd., Yoqneam9710107-2024-00202
- PILLCAMJul 12, 2024MalfunctionGiven Imaging Ltd., Yoqneam9710107-2024-00108
- CAPSULE ENDOSCOPYOct 20, 2022InjuryUnkMW5112783
- PILLCAMAug 19, 2022InjuryGiven Imaging Ltd., Yoqneam9710107-2022-00181
- PILLCAMNov 23, 2021InjuryGiven Imaging Ltd., Yoqneam9710107-2021-00480
- PILLCAMAug 12, 2021InjuryGiven Imaging Ltd., Yoqneam9710107-2021-00372
- PILLCAM COLON 2Jun 7, 2021InjuryGiven Imaging Ltd., Yoqneam9710107-2021-00273
- PILLCAMAug 17, 2020InjuryGiven Imaging Ltd., Yoqneam9710107-2020-00359
- PILLCAMOct 8, 2019InjuryGiven Imaging Ltd., Yoqneam9710107-2019-00446
Event type breakdown
Injury11
Malfunction3
Most-reported manufacturers
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
6 firms currently registered for this product code
510(k) clearances
2 clearances for this product code