System, Imaging, Esophageal, Wireless, Capsule
Given Imaging Ltd.'s record for this product code
MDR events16All time
Recalls0All time
510(k) clearances7All time
Recent MDR events
16 adverse event reports on file
- SMALL BOWEL CAPSULE RECORDER SB3Mar 26, 2020MalfunctionMW5093951
- PILLCAMJun 28, 2019Injury9710107-2019-00298
- PILLCAMMar 25, 2019Injury9710107-2019-00120
- PILLCAMMar 14, 2019Injury9710107-2019-00092
- UNKNOWN-BRAVODec 27, 2018Injury9710107-2018-01092
- UNKNOWN-BRAVODec 27, 2018Injury9710107-2018-01093
- UNKNOWN-BRAVODec 27, 2018Injury9710107-2018-01094
- PILLCAMNov 8, 2018Injury9710107-2018-01039
- PILLCAMNov 2, 2018Injury9710107-2018-01022
- PILLCAMOct 1, 2018Injury9710107-2018-00967
Recalls
0 recall events for this product code
No recalls on file for Given Imaging Ltd. under this product code.
510(k) clearances
7 clearances for this product code
- K180171Mar 8, 2018
PillCam Patency System
- K090557Sep 28, 2009
GIVEN PILLCAM PLATFORM WILL PILLCAM SB CAPSULES, ESO CAPSULES, GIVEN AGILE PATENCY SYSTEM
- K071153Jun 11, 2007
GIVEN DIAGNOSTIC SYSTEM WITH PILLCAM ESO2 CAPSULE
- K060805May 24, 2006
MODIFICATION TO GIVEN DIAGNOSTIC SYSTEM
- K052184Dec 1, 2005
GIVEN DIAGNOSTIC SYSTEM
- K042960Nov 24, 2004
GIVEN DIAGNOSTIC SYSTEM WITH PILLCAM ESO
- K041149Oct 25, 2004
GIVEN DIAGNOSTIC SYSTEM WITH M2A ESO CAPSULE