K212049 is an FDA 510(k) clearance for the Oclet TDS 1000. This device is classified as a Instrument, Ultrasonic Surgical.
Submitted by Tendonova Corporation (Norcross, US). The FDA issued a Cleared decision on March 8, 2022, 251 days after receiving the submission on June 30, 2021.
This device falls under the General & Plastic Surgery FDA review panel.
| 510(k) Number | K212049 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 30, 2021 |
| Decision Date | March 08, 2022 |
| Days to Decision | 251 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | LFL - Instrument, Ultrasonic Surgical |
| Device Class | - |