510(k) K123640
K123640 is an FDA 510(k) premarket notification submitted by Tenex Health for the device "TX1 TISSUE REMOVAL SYSTEM". The FDA issued a decision of Substantially Equivalent on March 20, 2013. The device falls under product code LFL (Instrument, Ultrasonic Surgical), a Class U device. Tenex Health has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 20, 2013
- Date Received
- November 26, 2012
- 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