510(k) K200427
K200427 is an FDA 510(k) premarket notification submitted by Covidien, LLC for the device "Sonicision Cordless Ultrasonic Dissector". The FDA issued a decision of Substantially Equivalent on Jul 10, 2020. The device falls under product code LFL (Instrument, Ultrasonic Surgical), a Class U device. Covidien, LLC has 224 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jul 10, 2020
- Date Received
- Feb 21, 2020
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Instrument, Ultrasonic Surgical
- Device Class
- Class U
- Review Panel
- SU
- Submission Type
- 510(k)