The following data is part of a premarket notification filed by Ethicon Endo-surgery, Llc with the FDA for Enseal Trio Tissue Sealing Device.
| Device ID | K123141 |
| 510k Number | K123141 |
| Device Name: | ENSEAL TRIO TISSUE SEALING DEVICE |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | ETHICON ENDO-SURGERY, LLC 4545 CREEK ROAD Cincinnati, OH 45242 |
| Contact | Emily Kreutzkamp |
| Correspondent | Emily Kreutzkamp ETHICON ENDO-SURGERY, LLC 4545 CREEK ROAD Cincinnati, OH 45242 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-10-05 |
| Decision Date | 2012-10-25 |
| Summary: | summary |