510(k) K190512 ยท FDI Snare, Flexible
SmartBand EMR Kit, SmartBand EMR Pack, SmartSnare
| Applicant | Intelligent Endoscopy, Clemmons NC, US |
| Decision | Substantially Equivalent, Nov 22, 2019 |
| Received | Mar 1, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K190512
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.