510(k) K180403 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
ENSEAL X1 Tissue Sealer, Curved Jaw, Articulating 37 cm Shaft Length; ENSEAL X1 Tissue Sealer, Curved Jaw, Articulating 45 cm Shaft Length
| Applicant | Ethicon Endo-Surgery, LLC, Guaynabo PR, US |
| Decision | Substantially Equivalent, May 23, 2018 |
| Received | Feb 14, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K180403
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.