510(k) K183171 ยท ODB Endoscopic Contamination Prevention Sheath
ScopeSeal Duodenoscope Protective Device
| Applicant | Gi Scientific, LLC, Arlington VA, US |
| Decision | Substantially Equivalent, Oct 8, 2019 |
| Received | Nov 16, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K183171
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.