The following data is part of a premarket notification filed by Covidien, Llc with the FDA for Het Bipolar Electrocautery Forceps, Het Bipolar Electrocautery Monitor.
| Device ID | K200146 |
| 510k Number | K200146 |
| Device Name: | HET Bipolar Electrocautery Forceps, HET Bipolar Electrocautery Monitor |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | Covidien, Llc 15 Hampshire Street Mansfield, MA 02048 |
| Contact | Shani Frenkel |
| Correspondent | Liron Bar Yaakov Covidien, Llc 6135 Gunbarrel Avenue 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 | 2020-01-22 |
| Decision Date | 2020-05-07 |