510(k) K212750
K212750 is an FDA 510(k) premarket notification submitted by Smtp Technology Co., Ltd. for the device "Ultrasonic Surgical Aspirator System, Model: XD880B". The FDA issued a decision of Substantially Equivalent on September 27, 2021. The device falls under product code LFL (Instrument, Ultrasonic Surgical), a Class U device. Smtp Technology Co., Ltd. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 27, 2021
- Date Received
- August 30, 2021
- Clearance Type
- Special
- 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