Small Foam Kit, Medium Foam Kit, Large Foam Kit, Extra Large Foam Kit— 510(k) K211571

Substantially Equivalent

Zhejiang Longterm Medical Technology Co., Ltd.

FDA 510(k) clearance K211571 for Small Foam Kit, Medium Foam Kit, Large Foam Kit, Extra Large Foam Kit, Substantially Equivalent on 2022-05-31. Applicant: Zhejiang Longterm Medical Technology Co., Ltd..

Clearance details

Applicant: Zhejiang Longterm Medical Technology Co., Ltd.
Product code: Code OMP
Advisory panel: General, Plastic Surgery
Date received: 2021-05-21
Decision date: 2022-05-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Deqing, CN

Download summary PDF View on FDA.gov ↗

Adverse events under product code OMP

product code OMP

Death: 31
Injury: 1,707
Malfunction: 4,047
Other: 1
Total: 5,786

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.