510(k) K181367
K181367 is an FDA 510(k) premarket notification submitted by Tenex Health, Inc. for the device "Tenex Health TX System with the TXP MicroTip". The FDA issued a decision of Substantially Equivalent on August 28, 2018. The device falls under product code LFL (Instrument, Ultrasonic Surgical), a Class U device. Tenex Health, Inc. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 28, 2018
- Date Received
- May 23, 2018
- 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