510(k) K201066 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
ENSEAL X1 Tissue Sealer, Curved Jaw, 25 cm Shaft Length, ENSEAL X1 Tissue Sealer, Curved Jaw, 37 cm Shaft Length, ENSEAL X1 Tissue Sealer, Curved Jaw, 45 cm Shaft Length
| Applicant | Ethicon Endo-Surgery, LLC, Guaynabo PR, US |
| Decision | Substantially Equivalent, Jan 22, 2021 |
| Received | Apr 22, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K201066
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.