The following data is part of a premarket notification filed by Given Imaging Ltd. with the FDA for Given Pillcam Platform Will Pillcam Sb Capsules, Eso Capsules, Given Agile Patency System.
| Device ID | K090557 |
| 510k Number | K090557 |
| Device Name: | GIVEN PILLCAM PLATFORM WILL PILLCAM SB CAPSULES, ESO CAPSULES, GIVEN AGILE PATENCY SYSTEM |
| Classification | System, Imaging, Esophageal, Wireless, Capsule |
| Applicant | GIVEN IMAGING LTD. NEW INDUSTRIAL PARK P.O. BOX 258 Yoqneam, IL 20692 |
| Contact | Tim Thomas |
| Correspondent | Tim Thomas GIVEN IMAGING LTD. NEW INDUSTRIAL PARK P.O. BOX 258 Yoqneam, IL 20692 |
| Product Code | NSI |
| CFR Regulation Number | 876.1300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-03-02 |
| Decision Date | 2009-09-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07290110360825 | K090557 | 000 |
| 07290110360818 | K090557 | 000 |
| 07290101360643 | K090557 | 000 |
| 07290101360636 | K090557 | 000 |
| 07290101360629 | K090557 | 000 |