The following data is part of a premarket notification filed by Covidien with the FDA for Ligasure; Curved Small Jaw Sealer/divider, 5mm Blunt Tip Sealer/divider, Maryland Jaw One Step Stealer/dividers, Curved.
| Device ID | K141153 |
| 510k Number | K141153 |
| Device Name: | LIGASURE; CURVED SMALL JAW SEALER/DIVIDER, 5MM BLUNT TIP SEALER/DIVIDER, MARYLAND JAW ONE STEP STEALER/DIVIDERS, CURVED |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | COVIDIEN 5920 LONGBOW DR. 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 | 2014-05-05 |
| Decision Date | 2014-08-14 |
| Summary: | summary |