The following data is part of a premarket notification filed by Valleylab with the FDA for Ligasure Vessel Sealing System. Ligasure Instruments.
| Device ID | K043273 |
| 510k Number | K043273 |
| Device Name: | LIGASURE VESSEL SEALING SYSTEM. LIGASURE INSTRUMENTS |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | VALLEYLAB 5920 LONGBOW DR. Boulder, CO 80301 |
| Contact | Herbert Vinson |
| Correspondent | Herbert Vinson VALLEYLAB 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 | 2004-11-26 |
| Decision Date | 2005-01-05 |
| Summary: | summary |