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

Substantially Equivalent

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

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.