The following data is part of a premarket notification filed by Covidien with the FDA for Ligasure Impact Curved, Large Jaw, Open Sealer/divider, Nano-coated.
| Device ID | K162047 |
| 510k Number | K162047 |
| Device Name: | LigaSure Impact Curved, Large Jaw, Open Sealer/Divider, Nano-coated |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | COVIDIEN 5920 LONGBOW DRIVE Boulder, CO 80301 |
| Contact | Celso Duran |
| Correspondent | Celso Duran COVIDIEN 5920 LONGBOW DRIVE Boulder, CO 80301 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-07-25 |
| Decision Date | 2016-09-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20884521612522 | K162047 | 000 |