The following data is part of a premarket notification filed by Ethicon Endo-surgery, Llc with the FDA for Enseal X1 Large Jaw Tissue Sealer.
| Device ID | K160554 |
| 510k Number | K160554 |
| Device Name: | Enseal X1 Large Jaw Tissue Sealer |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | ETHICON ENDO-SURGERY, LLC 4545 CREEK RD Cincinnati, OH 45242 |
| Contact | David Locke |
| Correspondent | David Locke ETHICON ENDO-SURGERY, LLC 4545 CREEK RD Cincinnati, OH 45242 |
| Product Code | GEI |
| Subsequent Product Code | HGI |
| Subsequent Product Code | LFL |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-02-29 |
| Decision Date | 2016-09-09 |
| Summary: | summary |