The following data is part of a premarket notification filed by Covidien with the FDA for Ligasure Curved Jaw, Open Sealer/divider Electrode, Ligasure Curved Jaw Open Reusable Clamp.
| Device ID | K160331 |
| 510k Number | K160331 |
| Device Name: | LigaSure Curved Jaw, Open Sealer/Divider Electrode, LigaSure Curved Jaw Open Reusable Clamp |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | Covidien 6F, Building 3, 2388 Chenhang Road Shanghai, CN 201114 |
| Contact | Hong Zhu |
| Correspondent | Hong Zhu Covidien 6F, Building 3, 2388 Chenhang Road Shanghai, CN 201114 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-02-08 |
| Decision Date | 2016-08-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20884521199399 | K160331 | 000 |
| 20884521197180 | K160331 | 000 |
| 20884521780559 | K160331 | 000 |
| 20884521780542 | K160331 | 000 |