Panels › Gastroenterology, Urology › Product code NSI · Class 2
System, Imaging, Esophageal, Wireless, Capsule
Regulation 876.1300
0510(k)s in 12 months (7 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in NSI
| Company | 510(k)s | Recalls |
|---|---|---|
| Given Imaging , Ltd. | 7 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 8, 2018 | K180171 | PillCam Patency System Given Imaging , Ltd., IL | NSI |
| Sep 28, 2009 | K090557 | GIVEN PILLCAM PLATFORM WILL PILLCAM SB CAPSULES, ESO CAPSULES, GIVEN AGILE PATENCY SYSTEM Given Imaging , Ltd., IL | NSI |
| Jun 11, 2007 | K071153 | GIVEN DIAGNOSTIC SYSTEM WITH PILLCAM ESO2 CAPSULE Given Imaging , Ltd., CA | NSI |
| May 24, 2006 | K060805 | MODIFICATION TO GIVEN DIAGNOSTIC SYSTEM Given Imaging , Ltd., IL | NSI |
| Dec 1, 2005 | K052184 | GIVEN DIAGNOSTIC SYSTEM Given Imaging , Ltd., IL | NSI |
| Nov 24, 2004 | K042960 | GIVEN DIAGNOSTIC SYSTEM WITH PILLCAM ESO Given Imaging , Ltd., IL | NSI |
| Oct 25, 2004 | K041149 | GIVEN DIAGNOSTIC SYSTEM WITH M2A ESO CAPSULE Given Imaging , Ltd., IL | NSI |
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