510(k) K153466 ยท PGD Colon Capsule Imaging System
PillCam COLON 2 Capsule Endoscopy System
| Applicant | Given Imaging , Ltd., Yoqneam, IL |
| Decision | Substantially Equivalent, Jan 14, 2016 |
| Received | Dec 1, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K153466
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.