The following data is part of a premarket notification filed by Ethicon Endo-surgery, Llc with the FDA for Ethicon Endo-surgery Enseal G2 Cordless Tissue Sealers.
| Device ID | K123212 |
| 510k Number | K123212 |
| Device Name: | ETHICON ENDO-SURGERY ENSEAL G2 CORDLESS TISSUE SEALERS |
| Classification | Electrosurgical Vessel And/or Tissue Sealer. With Built-in Generator. |
| Applicant | ETHICON ENDO-SURGERY, LLC 4545 CREEK ROAD Cincinnati, OH 45242 |
| Contact | Liping Wu |
| Correspondent | Liping Wu ETHICON ENDO-SURGERY, LLC 4545 CREEK ROAD Cincinnati, OH 45242 |
| Product Code | PDG |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-10-15 |
| Decision Date | 2013-03-08 |
| Summary: | summary |