The following data is part of a premarket notification filed by Given Imaging Ltd. with the FDA for Pillcam Colon 2 Capsule Endoscopy System.
| Device ID | K153466 |
| 510k Number | K153466 |
| Device Name: | PillCam COLON 2 Capsule Endoscopy System |
| Classification | Colon Capsule Imaging System |
| Applicant | GIVEN IMAGING LTD. 2 Hacarmel St. NEW INDUSTRIAL Park POB 258 Yoqneam, IL 20962 |
| Contact | Hilla Debby |
| Correspondent | Hilla Debby GIVEN IMAGING LTD. 2 Hacarmel St. NEW INDUSTRIAL Park POB 258 Yoqneam, IL 20962 |
| Product Code | PGD |
| CFR Regulation Number | 876.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-12-01 |
| Decision Date | 2016-01-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07290101364832 | K153466 | 000 |
| 07290101364825 | K153466 | 000 |
| 07290101364818 | K153466 | 000 |
| 07290101364801 | K153466 | 000 |
| 07290101364795 | K153466 | 000 |
| 07290101364788 | K153466 | 000 |