The following data is part of a premarket notification filed by Covidien with the FDA for Ligasure Maryland Jaw Thoracic Sealer/divider One-step Sealing, Nano-coated.
| Device ID | K181085 |
| 510k Number | K181085 |
| Device Name: | LigaSure Maryland Jaw Thoracic Sealer/Divider One-step Sealing, Nano-coated |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | Covidien 5920 Longbow Drive Boulder, CO 80301 |
| Contact | James R. Davis |
| Correspondent | James R. Davis Covidien 5920 Longbow Drive 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 | 2018-04-25 |
| Decision Date | 2018-06-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20884521751047 | K181085 | 000 |