510(k) K230387 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
ENSEAL X1 Curved Tissue Sealers, 25 cm shaft length (NSLX125C); ENSEAL X1 Curved Tissue Sealers, 37 cm shaft length (NSLX137C); ENSEAL X1 Curved Tissue Sealers, 45 cm shaft ength (NSLX137C); ENSEAL X1 Straight Tissue Sealers, 25 cm shaft length (NSLX125S); ENSEAL X1 Straight Tissue Sealers, 37 cm sh
| Applicant | Ethicon Endo-Surgery, LLC, Guaynabo PR, US |
| Decision | Substantially Equivalent, Apr 13, 2023 |
| Received | Feb 14, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K230387
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.