The following data is part of a premarket notification filed by Ethicon Endo-surgery, Llc with the FDA for Enseal G2 Tissue Sealer, Straight Jaw, Enseal G2 Tissue Sealer, Curved Jaw, Enseal Trio Tissue Sealer, 3 Mm Curved Jaw,.
| Device ID | K131435 |
| 510k Number | K131435 |
| Device Name: | ENSEAL G2 TISSUE SEALER, STRAIGHT JAW, ENSEAL G2 TISSUE SEALER, CURVED JAW, ENSEAL TRIO TISSUE SEALER, 3 MM CURVED JAW, |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | ETHICON ENDO-SURGERY, LLC 4545 CREEK ROAD Cincinnati, OH 45242 |
| Contact | Marica Arentz |
| Correspondent | Marica Arentz ETHICON ENDO-SURGERY, LLC 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 | 2013-05-20 |
| Decision Date | 2013-10-03 |
| Summary: | summary |