The following data is part of a premarket notification filed by Covidien, Formerly Valleylab, A Division Of Tyco H with the FDA for Ligasure Impact Curved, Large Jaw, Open Sealer / Divider.
| Device ID | K123444 |
| 510k Number | K123444 |
| Device Name: | LIGASURE IMPACT CURVED, LARGE JAW, OPEN SEALER / DIVIDER |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | COVIDIEN, FORMERLY VALLEYLAB, A DIVISION OF TYCO H 5920 Longbow Dr Boulder, CO 80301 |
| Contact | Dawn Tindall |
| Correspondent | Dawn Tindall COVIDIEN, FORMERLY VALLEYLAB, A DIVISION OF TYCO H 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 | 2012-11-08 |
| Decision Date | 2013-01-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20884521165318 | K123444 | 000 |