Ultrasonic Surgical Aspirator System, Model: XD880B— 510(k) K212750

Substantially Equivalent

Smtp 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..

Clearance details

Applicant: Smtp Technology Co., Ltd.
Product code: Code LFL
Advisory panel: Unknown
Date received: 2021-08-30
Decision date: 2021-09-27
Decision: Substantially Equivalent
Clearance type: Special
Location: Zhangjiagang, CN

Download summary PDF View on FDA.gov ↗

Adverse events under product code LFL

product code LFL

Death: 29
Injury: 1,046
Malfunction: 21,642
Total: 22,717

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.