K241700 is an FDA 510(k) clearance for the Tenex 2nd Generation System. This device is classified as a Instrument, Ultrasonic Surgical.
Submitted by Trice Medical, Inc. (Malvern, US). The FDA issued a Cleared decision on November 18, 2024, 158 days after receiving the submission on June 13, 2024.
This device falls under the General & Plastic Surgery FDA review panel.
| 510(k) Number | K241700 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 13, 2024 |
| Decision Date | November 18, 2024 |
| Days to Decision | 158 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | LFL - Instrument, Ultrasonic Surgical |
| Device Class | - |