510(k) K180149
K180149 is an FDA 510(k) premarket notification submitted by Covidien, LLC for the device "Sonicision Reusable Generator, Sonicision Reusable Battery Pack, Sonicision Curved Jaw Dissectors (multiple lengths), Sonicision Battery Charger, Sonicision Battery Insertion Guide". The FDA issued a decision of Substantially Equivalent on Mar 26, 2018. 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
- Mar 26, 2018
- Date Received
- Jan 19, 2018
- Clearance Type
- Traditional
- 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)