K212750 is an FDA 510(k) clearance for the Ultrasonic Surgical Aspirator System, Model: XD880B. This device is classified as a Instrument, Ultrasonic Surgical.
Submitted by Smtp Technology Co., Ltd. (Zhangjiagang, CN). The FDA issued a Cleared decision on September 27, 2021, 28 days after receiving the submission on August 30, 2021.
This device falls under the General & Plastic Surgery FDA review panel.
| 510(k) Number | K212750 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 30, 2021 |
| Decision Date | September 27, 2021 |
| Days to Decision | 28 days |
| Submission Type | Special |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | LFL - Instrument, Ultrasonic Surgical |
| Device Class | - |