The following data is part of a premarket notification filed by Ethicon Endo-surgery, Llc with the FDA for Enseal X1 Tissue Sealer, Curved Jaw, Articulating 37 Cm Shaft Length; Enseal X1 Tissue Sealer, Curved Jaw, Articulating 45 Cm Shaft Length.
| Device ID | K180403 |
| 510k Number | K180403 |
| Device Name: | ENSEAL X1 Tissue Sealer, Curved Jaw, Articulating 37 Cm Shaft Length; ENSEAL X1 Tissue Sealer, Curved Jaw, Articulating 45 Cm Shaft Length |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | Ethicon Endo-Surgery, LLC 475 Calle C Guaynabo, PR 00969 |
| Contact | Sigfrido Delgado |
| Correspondent | Kweku Biney Ethicon Endo-Surgery, Inc. 4545 Creek Road Cincinnati, OH 45242 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-02-14 |
| Decision Date | 2018-05-23 |
| Summary: | summary |