The following data is part of a premarket notification filed by Valleylab with the FDA for Ligasure 5mm Blunt Tip Laparoscopic Sealer-divider.
| Device ID | K092879 |
| 510k Number | K092879 |
| Device Name: | LIGASURE 5MM BLUNT TIP LAPAROSCOPIC SEALER-DIVIDER |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | VALLEYLAB 5920 LONGBOW DR. Boulder, CO 80301 |
| Contact | Philip E Ake |
| Correspondent | Philip E Ake VALLEYLAB 5920 LONGBOW DR. Boulder, CO 80301 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-09-18 |
| Decision Date | 2009-10-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20884524002290 | K092879 | 000 |
| 20884521125527 | K092879 | 000 |
| 20884521124872 | K092879 | 000 |