The following data is part of a premarket notification filed by Covidien with the FDA for Ligasure Maryland Jaw Sealer/divider One-step Sealing, Nano-coated.
| Device ID | K170869 |
| 510k Number | K170869 |
| Device Name: | LigaSure Maryland Jaw Sealer/Divider One-step Sealing, Nano-coated |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | Covidien 5920 Longbow Drive Boulder, CO 80301 |
| Contact | Celso Duran |
| Correspondent | Celso Duran Covidien 5920 Longbow Drive 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 | 2017-03-23 |
| Decision Date | 2017-04-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20884521705927 | K170869 | 000 |
| 20884521705910 | K170869 | 000 |
| 20884521705903 | K170869 | 000 |