The following data is part of a premarket notification filed by Ethicon Endo-sugery, Llc with the FDA for Enseal G2 Tissus Sealers.
| Device ID | K112033 |
| 510k Number | K112033 |
| Device Name: | ENSEAL G2 TISSUS SEALERS |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | ETHICON ENDO-SUGERY, LLC 4545 CREEK RD. Cincinnati, OH 45242 |
| Contact | Donovan May |
| Correspondent | Donovan May ETHICON ENDO-SUGERY, LLC 4545 CREEK RD. 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 | 2011-07-15 |
| Decision Date | 2011-11-08 |
| Summary: | summary |