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 | K163548 |
| 510k Number | K163548 |
| Device Name: | ENSEAL X1 Large Jaw Tissue Sealer |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | Ethicon Endo-Surgery, LLC 475 Calle C Guaynabo, PR 00969 |
| Contact | Marjorie Medina |
| Correspondent | David Locke Ethicon Endo-Surgery, LLC 4545 Creek Road Cincinnate, 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 | 2016-12-16 |
| Decision Date | 2017-02-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20705036015021 | K163548 | 000 |