510(k) K183112 · GEI Electrosurgical, Cutting & Coagulation & Accessories
DiLumen Endolumenal Interventional Knife (DiLumen IK)
| Applicant | Lumendi, LLC, Westport CT, US |
| Decision | Substantially Equivalent, Aug 2, 2019 |
| Received | Nov 8, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K183112
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.