The following data is part of a premarket notification filed by Covidien with the FDA for Bizact Open Sealer/divider.
| Device ID | K160539 |
| 510k Number | K160539 |
| Device Name: | BiZact Open Sealer/Divider |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | COVIDIEN 5920 LONGBOW DR. Boulder, CO 80301 |
| Contact | Sharon Mcdermott |
| Correspondent | Sharon Mcdermott COVIDIEN 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 | 2016-02-26 |
| Decision Date | 2016-06-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20884521552453 | K160539 | 000 |