LUOFUCON Silicone Ag Foam Dressing with Border— 510(k) K170077

Substantially Equivalent

Huizhou Foryou Medical Devices Co., Ltd.

FDA 510(k) clearance K170077 for LUOFUCON Silicone Ag Foam Dressing with Border, Substantially Equivalent on 2017-03-30. Applicant: Huizhou Foryou Medical Devices Co., Ltd..

Clearance details

Applicant: Huizhou Foryou Medical Devices Co., Ltd.
Product code: Code FRO
Advisory panel: Unknown
Date received: 2017-01-09
Decision date: 2017-03-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Huizhou, CN

Download summary PDF View on FDA.gov ↗

Adverse events under product code FRO

product code FRO

Death: 30
Injury: 653
Malfunction: 479
Other: 11
Total: 1,173

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.