The following data is part of a premarket notification filed by Given Imaging Ltd. with the FDA for Given Pillcam Ugi Capsule Endoscopy System.
| Device ID | K140284 |
| 510k Number | K140284 |
| Device Name: | GIVEN PILLCAM UGI CAPSULE ENDOSCOPY SYSTEM |
| Classification | System, Imaging, Gastrointestinal, Wireless, Capsule |
| Applicant | GIVEN IMAGING LTD. 2 Hacarmel St. NEW INDUSTRIAL Park, POB 258 Yoqneam, IL 20692 |
| Contact | Hila Debby |
| Correspondent | Hila Debby GIVEN IMAGING LTD. 2 Hacarmel St. NEW INDUSTRIAL Park, POB 258 Yoqneam, IL 20692 |
| Product Code | NEZ |
| CFR Regulation Number | 876.1300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-02-04 |
| Decision Date | 2014-12-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07290101366270 | K140284 | 000 |
| 07290101366263 | K140284 | 000 |
| 07290101366256 | K140284 | 000 |