The following data is part of a premarket notification filed by Ethicon Endo-surgery, Llc with the FDA for Enseal G2 Articulating Tissue Sealers, Straight Jaw, Enseal G2 Articulating Tissue Sealers, Curved Jaw.
| Device ID | K122797 |
| 510k Number | K122797 |
| Device Name: | ENSEAL G2 ARTICULATING TISSUE SEALERS, STRAIGHT JAW, ENSEAL G2 ARTICULATING TISSUE SEALERS, CURVED JAW |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | ETHICON ENDO-SURGERY, LLC 4545 CREEK ROAD Cincinnati, OH 45242 |
| Contact | Emily Kruetzkamp |
| Correspondent | Emily Kruetzkamp 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 | 2012-09-12 |
| Decision Date | 2013-01-25 |
| Summary: | summary |