The following data is part of a premarket notification filed by Covidien Llc with the FDA for Sonicision Cordless Ultrasonic Dissection Device.
| Device ID | K153371 |
| 510k Number | K153371 |
| Device Name: | Sonicision Cordless Ultrasonic Dissection Device |
| Classification | Instrument, Ultrasonic Surgical |
| Applicant | COVIDIEN LLC 5920 LONGBOW DRIVE Boulder, CO 80301 |
| Contact | Nancy Sauer |
| Correspondent | Nancy Sauer COVIDIEN LLC 5920 LONGBOW DRIVE 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 | 2015-11-23 |
| Decision Date | 2016-03-28 |
| Summary: | summary |