The following data is part of a premarket notification filed by Covidien, Formerly Valleylab, with the FDA for Lugasure Curved, Small Jaw, Open Sealer/divider.
| Device ID | K102470 |
| 510k Number | K102470 |
| Device Name: | LUGASURE CURVED, SMALL JAW, OPEN SEALER/DIVIDER |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | COVIDIEN, FORMERLY VALLEYLAB, 5920 LONGBOW DRIVE Boulder, CO 80301 |
| Contact | David M Horton |
| Correspondent | David M Horton COVIDIEN, FORMERLY VALLEYLAB, 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 | 2010-08-30 |
| Decision Date | 2011-02-07 |
| Summary: | summary |