Ultrasonic Surgical Aspirator System, Model: XD880B— 510(k) K212750
Substantially EquivalentSmtp Technology Co., Ltd.
FDA 510(k) clearance K212750 for Ultrasonic Surgical Aspirator System, Model: XD880B, Substantially Equivalent on 2021-09-27. Applicant: Smtp Technology Co., Ltd.. Device class: Unclassified.
Clearance details
- Applicant
- Smtp Technology Co., Ltd.
- Product code
- Product code LFL
- Device class
- Unclassified
- Advisory panel
- Unknown
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Zhangjiagang, CN
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More clearances from Smtp Technology Co., Ltd.
view allAdverse events under product code LFL
product code LFL- Death
- 29
- Injury
- 1,046
- Malfunction
- 21,642
- Total
- 22,717
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.