K241700 is an FDA 510(k) clearance for the Tenex 2nd Generation System, 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 review panel.
| 510(k) Number | K241700 FDA.gov |
| FDA Decision | Cleared 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 | — |