The following data is part of a premarket notification filed by Covidien with the FDA for Ligasure Advance Monopolar Tip Laparoscopic Sealer/divider, Pistol Grip.
| Device ID | K150835 |
| 510k Number | K150835 |
| Device Name: | LigaSure Advance Monopolar Tip Laparoscopic Sealer/Divider, Pistol Grip |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | COVIDIEN 5920 Longbow Drive Boulder, CO 80301 |
| Contact | Nancy Sauer |
| Correspondent | Nancy Sauer COVIDIEN 5920 Longbow Drive Boulder, CO 80301 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-03-30 |
| Decision Date | 2015-10-15 |
| Summary: | summary |