510(k) K212049
K212049 is an FDA 510(k) premarket notification submitted by Tendonova Corporation for the device "Oclet TDS 1000". The FDA issued a decision of Substantially Equivalent on March 8, 2022. The device falls under product code LFL (Instrument, Ultrasonic Surgical), a Class U device.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 8, 2022
- Date Received
- June 30, 2021
- 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