K123212 is an FDA 510(k) clearance for the ETHICON ENDO-SURGERY ENSEAL G2 CORDLESS TISSUE SEALERS. This device is classified as a Electrosurgical Vessel And/or Tissue Sealer. With Built-in Generator. (Class II - Special Controls, product code PDG).
Submitted by Ethicon Endo-Surgery, LLC (Cincinnati, US). The FDA issued a Cleared decision on March 8, 2013, 144 days after receiving the submission on October 15, 2012.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4400. Intended For Any Procedure Where Vessel Ligation (cutting And Sealing), Soft Tissue Grasping And Dissection Are Performed..
| 510(k) Number | K123212 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 15, 2012 |
| Decision Date | March 08, 2013 |
| Days to Decision | 144 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | PDG — Electrosurgical Vessel And/or Tissue Sealer. With Built-in Generator. |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4400 |
| Definition | Intended For Any Procedure Where Vessel Ligation (cutting And Sealing), Soft Tissue Grasping And Dissection Are Performed. |