The following data is part of a premarket notification filed by Valleylab, Inc. with the FDA for Ligasure 5mm Laparoscopic Sealer-divider, Model Ls1500.
| Device ID | K031011 |
| 510k Number | K031011 |
| Device Name: | LIGASURE 5MM LAPAROSCOPIC SEALER-DIVIDER, MODEL LS1500 |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | VALLEYLAB, INC. 5920 LONGBOW DR. Boulder, CO 80301 |
| Contact | Herbert Vinson |
| Correspondent | Herbert Vinson VALLEYLAB, INC. 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 | 2003-03-31 |
| Decision Date | 2003-05-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10884524000275 | K031011 | 000 |
| 40884524002188 | K031011 | 000 |
| 20884521780535 | K031011 | 000 |
| 20884521780528 | K031011 | 000 |
| 20884521171890 | K031011 | 000 |