The following data is part of a premarket notification filed by Valleylab, Inc. with the FDA for Ligasure Laparoscopic Sealer Divider Model Ls1100.
| Device ID | K010013 |
| 510k Number | K010013 |
| Device Name: | LIGASURE LAPAROSCOPIC SEALER DIVIDER MODEL LS1100 |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | VALLEYLAB, INC. 5920 LONGBOW DR. Boulder, CO 80301 |
| Contact | Kevin Randall |
| Correspondent | Kevin Randall 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 | 2001-01-02 |
| Decision Date | 2001-03-26 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20884524001637 | K010013 | 000 |
| 20884524001620 | K010013 | 000 |