The following data is part of a premarket notification filed by Given Imaging Ltd. with the FDA for Pillcam Patency System.
| Device ID | K180171 |
| 510k Number | K180171 |
| Device Name: | PillCam Patency System |
| Classification | System, Imaging, Esophageal, Wireless, Capsule |
| Applicant | Given Imaging Ltd. 2 Hacarmet St. New Industrial Park POB 258 Yoqneam, IL 20692 |
| Contact | Hilla Debby |
| Correspondent | Hilla Debby Given Imaging Ltd. 2 Hacarmet St. New Industrial Park POB 258 Yoqneam, IL 20692 |
| Product Code | NSI |
| Subsequent Product Code | NEZ |
| Subsequent Product Code | PGD |
| CFR Regulation Number | 876.1300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-01-22 |
| Decision Date | 2018-03-08 |
| Summary: | summary |