Tzoar 207 Negative Pressure Wound Therapy (NPWT) System— 510(k) K202898

Substantially Equivalent

Lightstone Medical Products (Ningbo) Co, Ltd.

FDA 510(k) clearance K202898 for Tzoar 207 Negative Pressure Wound Therapy (NPWT) System, Substantially Equivalent on 2021-12-30. Applicant: Lightstone Medical Products (Ningbo) Co, Ltd..

Clearance details

Applicant: Lightstone Medical Products (Ningbo) Co, Ltd.
Product code: Code OMP
Advisory panel: General, Plastic Surgery
Date received: 2020-09-29
Decision date: 2021-12-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ningbo, 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.