FDA Product Code
FDA Product Code NSI — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Gastroenterology, Urology
- 21 CFR Citation
- 876.1300
510(k) Clearances — 7 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K180171 | PillCam Patency System | Given Imaging , Ltd. | 2018-03-08 | Traditional | PDF ↗ |
| K090557 | GIVEN PILLCAM PLATFORM WILL PILLCAM SB CAPSULES, ESO CAPSULES, GIVEN AGILE PATENCY SYSTEM | Given Imaging , Ltd. | 2009-09-28 | Traditional | PDF ↗ |
| K071153 | GIVEN DIAGNOSTIC SYSTEM WITH PILLCAM ESO2 CAPSULE | Given Imaging , Ltd. | 2007-06-11 | Special | PDF ↗ |
| K060805 | MODIFICATION TO GIVEN DIAGNOSTIC SYSTEM | Given Imaging , Ltd. | 2006-05-24 | Special | PDF ↗ |
| K052184 | GIVEN DIAGNOSTIC SYSTEM | Given Imaging , Ltd. | 2005-12-01 | Traditional | PDF ↗ |
| K042960 | GIVEN DIAGNOSTIC SYSTEM WITH PILLCAM ESO | Given Imaging , Ltd. | 2004-11-24 | Special | PDF ↗ |
| K041149 | GIVEN DIAGNOSTIC SYSTEM WITH M2A ESO CAPSULE | Given Imaging , Ltd. | 2004-10-25 | Traditional | PDF ↗ |
Product code NSI · Class II · Gastroenterology, Urology. Data: openFDA.