510(k) K150682
K150682 is an FDA 510(k) premarket notification submitted by Integra Lifesciences Corp. for the device "CUSA Excel+". The FDA issued a decision of Substantially Equivalent on December 18, 2015. The device falls under product code LFL (Instrument, Ultrasonic Surgical), a Class U device. Integra Lifesciences Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 18, 2015
- Date Received
- March 17, 2015
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Instrument, Ultrasonic Surgical
- Device Class
- Class U
- Regulation Number
- Review Panel
- SU
- Submission Type