The following data is part of a premarket notification filed by Covidien Llc with the FDA for Edge Insulated Blade Electrode.
| Device ID | K210338 |
| 510k Number | K210338 |
| Device Name: | Edge Insulated Blade Electrode |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | Covidien LLC 5920 Longbow Drive Boulder, CO 80301 |
| Contact | Miranda Miles |
| Correspondent | Miranda Miles 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 | 2021-02-05 |
| Decision Date | 2021-04-15 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20884524001477 | K210338 | 000 |
| 30884524000613 | K210338 | 000 |
| 20884521803661 | K210338 | 000 |
| 10884521037120 | K210338 | 000 |