510(k) K241700
K241700 is an FDA 510(k) premarket notification submitted by Trice Medical, Inc. for the device "Tenex 2nd Generation System". The FDA issued a decision of Substantially Equivalent on November 18, 2024. The device falls under product code LFL (Instrument, Ultrasonic Surgical), a Class U device. Trice Medical, Inc. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 18, 2024
- Date Received
- June 13, 2024
- 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