510(k) K163495 ยท NEZ System, Imaging, Gastrointestinal, Wireless, Capsule
AdvanCE capsule endoscope delivery device
| Applicant | United States Endoscopy Group, Inc., Mentor OH, US |
| Decision | Substantially Equivalent, Mar 10, 2017 |
| Received | Dec 13, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K163495
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.