510(k) K101200 ยท NEZ System, Imaging, Gastrointestinal, Wireless, Capsule
PILLCAM EXPRESS VIDEO CAPSULES DELIVERY DEVICE
| Applicant | Given Imaging , Ltd., Yokneam (P.O.Box 258), IL |
| Decision | Substantially Equivalent, Sep 30, 2010 |
| Received | Apr 29, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K101200
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 23, 2011 | Given Imaging Ltd. Given Imaging Limited, PillCam Express Delivery Device, For use with PillCam SB, endoscopic imaging device. Part numbers FGS-0367 (3-Pak) or FGS-0366 (1-Pak). Terminated |
NEZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.