510(k) K172580 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
ENSEAL X1 Tissue Sealer, Straight Jaw, 25 cm Shaft Length, ENSEAL X1 Tissue Sealer, Straight Jaw, 37 cm Shaft Length, 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, Nov 20, 2017 |
| Received | Aug 28, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K172580
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 15, 2019 | Ethicon Endo-Surgery Inc Ethicon ENSEAL X1 Curved Jaw Tissue Sealer 25cm Shaft
PRODUCT CODE: NSLX125C Terminated |
GEI | None listed |
| May 15, 2019 | Ethicon Endo-Surgery Inc Ethicon ENSEAL X1 Curved Jaw Tissue Sealer 37cm Shaft
PRODUCT CODE: NSLX137C Terminated |
GEI | None listed |
| May 15, 2019 | Ethicon Endo-Surgery Inc Ethicon ENSEAL X1 Curved Jaw Tissue Sealer 45cm Shaft
PRODUCT CODE: NSLX145C Terminated |
GEI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.