The following data is part of a premarket notification filed by Covidien, Llc with the FDA for Bizact Tonsillectomy Device Advanced Bipolar Tissue Sealer/divider.
| Device ID | K193356 |
| 510k Number | K193356 |
| Device Name: | BiZact Tonsillectomy Device Advanced Bipolar Tissue Sealer/Divider |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | Covidien, LLC 5920 Longbow Drive Boulder, CO 80301 |
| Contact | Juma Hoshino |
| Correspondent | Juma Hoshino Covidien, LLC 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 | 2019-12-04 |
| Decision Date | 2020-03-02 |