The following data is part of a premarket notification filed by Covidien, Llc with the FDA for Sonicision 7 Curved Jaw Cordless Ultrasonic Dissection Device.
| Device ID | K212301 |
| 510k Number | K212301 |
| Device Name: | Sonicision 7 Curved Jaw Cordless Ultrasonic Dissection Device |
| Classification | Instrument, Ultrasonic Surgical |
| Applicant | Covidien, LLC 5920 Longbow Dr. Boulder, CO 80301 |
| Contact | Celso Duran |
| Correspondent | Celso Duran Covidien, LLC 5920 Longbow Dr. Boulder, CO 80301 |
| Product Code | LFL |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-07-23 |
| Decision Date | 2021-11-15 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20884521794808 | K212301 | 000 |
| 20884521794792 | K212301 | 000 |