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, 25 Cm Shaft Length, Enseal X1 Tissue Sealer, Curved Jaw, 37 Cm Shaft Length, Enseal X1 Tissue Sealer, Curved Jaw, 45 Cm Shaft Length.
| Device ID | K201066 |
| 510k Number | K201066 |
| Device Name: | 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 |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | Ethicon Endo-Surgery, LLC 475 Calle C Guaynabo, PR 00969 |
| Contact | Nathan Anderson |
| 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 | 2020-04-22 |
| Decision Date | 2021-01-22 |