510(k) K163548 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
ENSEAL X1 Large Jaw Tissue Sealer
| Applicant | Ethicon Endo-Surgery, LLC, Guaynabo PR, US |
| Decision | Substantially Equivalent, Feb 14, 2017 |
| Received | Dec 16, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K163548
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.