The following data is part of a premarket notification filed by Given Imaging Ltd. with the FDA for Pillcam Sbc Capsule Endoscopy System, Pilcam Desktop Software 9.0.
| Device ID | K170210 |
| 510k Number | K170210 |
| Device Name: | PillCam SBC Capsule Endoscopy System, PilCam Desktop Software 9.0 |
| Classification | System, Imaging, Gastrointestinal, 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 | NEZ |
| CFR Regulation Number | 876.1300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-01-24 |
| Decision Date | 2017-09-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07290110360566 | K170210 | 000 |
| 07290101369530 | K170210 | 000 |
| 07290110360191 | K170210 | 000 |
| 07290110360214 | K170210 | 000 |
| 07290110360221 | K170210 | 000 |
| 07290110360719 | K170210 | 000 |
| 07290110361167 | K170210 | 000 |
| 07290101366522 | K170210 | 000 |
| 07290110360801 | K170210 | 000 |
| 07290101366751 | K170210 | 000 |
| 07290101366768 | K170210 | 000 |
| 07290110360542 | K170210 | 000 |
| 07290110360559 | K170210 | 000 |
| 07290110360795 | K170210 | 000 |